Silicone hydrogel contact lenses

ABSTRACT

Silicone hydrogel contact lenses are produced without using volatile organic solvents to extract materials from the polymerized contact lens bodies, and instead are washed with aqueous liquids. The silicone hydrogel contact lenses so produced have ophthalmically wettable lens surfaces such that less than five percent of a batch of twenty or more such silicone hydrogel contact lenses have visually identifiable non-wetting spots when the contact lenses are located on eyes of subjects.

This application claims the benefit under 35 U.S.C. §119(e) of priorU.S. Provisional Patent Application No. 61/447,161, filed Feb. 28, 2011,which is incorporated in its entirety by reference herein.

FIELD

The present disclosure is directed to silicone hydrogel contact lensesand related compositions and methods.

BACKGROUND

Commercially and clinically, silicone hydrogel contact lenses are apopular alternative to conventional hydrogel contact lenses (i.e.,hydrogel contact lenses that do not contain silicone orsilicone-containing ingredients). The presence of hydrophobicingredients, such as siloxanes and other hydrophobic reactiveingredients, in silicone hydrogel contact lens formulations is believedto contribute, at least in part, to the frequent occurrence ofclinically ophthalmically unacceptable surface wettabilities associatedwith the development of new silicone hydrogel contact lenses. Forexample, a silicone hydrogel contact lens can be determined to have aclinically ophthalmically unacceptable surface wettability if visuallyidentifiable (identifiable under magnification) “non-wetting spots” areobserved on a lens surface by an eye care practitioner usingconventional techniques, such as slit lamp examinations. A non-wettingspot appears as a discontinuity or disruption in the lens wearer'spre-lens tear film present on the anterior surface of the siliconehydrogel contact lens provided on the eye. A non-wetting spot differsfrom a dry spot in that a non-wetting spot is a spot on a surface of thecontact lens that does not become covered with tear film, even after thelens wearer blinks. In contrast, a dry spot as understood in the art, isa spot on a surface of the contact lens that is covered with pre-lenstear film after a blink and where the pre-lens tear film is disrupted orbroken after an amount of time. It is believed that non-wetting spotsmay be attributed to increased amounts of hydrophobic lens material,such as siloxanes, present at the location of the non-wetting spots,compared to other regions of the lens surface that are wettable withpre-lens tear film.

The commercial manufacture of silicone hydrogel contact lensesfrequently includes one or more washing steps using volatile organicsolvents, such as alcohol, to remove unreacted or partially reactedchemicals, especially hydrophobic chemical ingredients, from thepolymerized lens bodies prior to packaging. This is frequently referredto as an extraction process to remove extractable material from thepolymerized silicone hydrogel contact lens product. Following extractionthe lens is then rinsed and hydrated using an aqueous solution. The useof volatile organic solvents facilitates removal of a component of thepolymerized silicone hydrogel contact lens that has poor solubility inaqueous solutions or water. However, the use of volatile organicsolvents presents safety risks to contact lens manufacturing sites, andcan be associated with increased costs of goods.

In addition to extracting with volatile organic solvents, a variety ofadditional manufacturing techniques have been employed to make siliconehydrogel contact lenses having clinically ophthalmically compatible lenssurfaces. For example, some silicone hydrogel contact lenses are treatedwith plasma to form a hydrophilic lens surface; some silicone hydrogelcontact lenses are formed from a polymerizable lens formulationcontaining a hydrophilic polymeric internal wetting agent, such aspolyvinyl pyrrolidone (PVP); some silicone hydrogel contact lenses areformed using polar resin contact lens molds instead of non-polar resincontact lens molds, and the lenses do not contain a hydrophilicpolymeric internal wetting agent in the polymerizable lens formulation,and are not subject to plasma treatment; and some silicone hydrogelcontact lenses are formed in non-polar resin molds and are provided withophthalmically compatible lens surfaces based on chemical reactivityproperties of the chemicals in the polymerizable lens formulation.

Recently silicone hydrogel contact lenses have been produced andprescribed as daily disposable contact lenses (e.g., the 1-DAY ACUVUETRUEYE (launched in the United Kingdom in 2008) and CLARITI 1-DAY(launched in the United Kingdom in November 2009); both apparentlyavailable in Europe. The lens material for 1-DAY ACUVUE TRUEYE contactlenses has a US Adopted Name (USAN) of Narafilcon A, and now morerecently, Narafilcon B. The lens material for CLARITI 1-DAY contactlenses has a USAN of Filcon II 3. It has been published that the TRUEYE(Narafilcon A) contact lenses have a water content of 54%, an oxygenpermeability (at −3.00 D, center, non-edge corrected) of 100 Dk; anoxygen transmissibility (10⁻⁹ at −3.00 D) of 118 Dk/t, a modulus of 0.66MPa, and are associated with a wetting agent/process. It has beenpublished that the CLARITI 1-DAY contact lenses have a water content of56%, an oxygen permeability (at −3.00 D, center, non-edge corrected) of60 Dk; an oxygen transmissibility (10⁻⁹ at −3.00 D) of 86 Dk/t, amodulus of 0.50 MPa, and are associated with a wetting agent/process.

As understood in the industry, a daily disposable contact lens is acontact lens that is removed from its sealed, sterilized package(primary package) produced by a contact lens manufacturer, placed on aperson's eye, and is removed and discarded after the person is donewearing the lens at the end of the day. Typically, the duration of lenswear for daily disposable contact lenses is between eight and fourteenhours, and they are not cleaned or exposed to cleaning solutions priorto placement in the eye since they are sterile prior to opening thepackage and then disposed. Thus, a daily disposable silicone hydrogelcontact lens is a disposable silicone hydrogel contact lens that isreplaced daily. In contrast, non-daily disposable contact lenses aredisposable contact lenses that are replaced less frequently than daily(e.g., weekly, bi-weekly, or monthly). Non-daily disposable contactlenses are either removed from the eye and cleaned with a cleaningsolution on a regular basis, or are worn continuously without removalfrom the eye.

In addition to modality differences, the manufacture of daily disposablecontact lenses can require changes in chemicals used to make the lenses,changes in manufacturing processes, or both, compared to non-dailydisposable contact lenses in order to produce a commercially acceptablenumber of lenses in a cost-effective manner.

Based on the popularity of silicone hydrogel contact lenses, therecontinues to be a need for new silicone hydrogel contact lenses that areophthalmically compatible.

Some documents describing silicone hydrogel contact lenses include: U.S.Pat. No. 4,711,943, U.S. Pat. No. 5,712,327, U.S. Pat. No. 5,760,100,U.S. Pat. No. 7,825,170, U.S. Pat. No. 6,867,245, US20060063852,US20070296914, U.S. Pat. No. 7,572,841, US20090299022, US20090234089,and US20100249356, each of which is incorporated in its entirety byreference herein.

SUMMARY

It has been realized that reducing or eliminating organic solvent basedextraction steps in the manufacture of silicone hydrogel contact lensesprovides at least one opportunity to reduce costs associated with themanufacture of daily disposable silicone hydrogel contact lenses.However, by replacing organic solvent based extraction steps, such asextracting silicone hydrogel contact lenses with alcohol-based liquidsand the like, with aqueous washing steps, it has become apparent thatreducing the occurrence of clinical non-wetting spots on such washedsilicone hydrogel contact lenses is difficult. Additionally, the use ofaqueous washing liquids free of volatile organic solvents can eliminatethe need for a separate rinsing and hydration step.

New silicone hydrogel contact lenses have been invented. The presentcontact lenses comprise, or consist of, lens bodies comprising apolymeric component and a liquid component. The polymeric componentcomprises units of one or more siloxanes, and one or more non-siloxanereactive ingredients. It can therefore be understood that the polymericcomponent is the reaction product of a polymerizable compositioncomprising one or more siloxanes, and one or more non-siloxane reactiveingredients. The ingredients of the polymerizable composition can bemonomers, macromers, pre-polymers, polymers, or combinations thereof.The combination of the polymeric component and the liquid component ispresent as a hydrated silicone hydrogel contact lens, which is suitablefor placement on an eye of a person. The contact lens comprises a convexanterior surface and a concave posterior surface, and has an equilibriumwater content (EWC) greater than 10% weight by weight (wt/wt). Duringthe manufacture of the silicone hydrogel contact lenses, the lens bodieshave not been extracted with a volatile organic solvent, such as aliquid composition comprising, consisting essentially of, or consistingof, a volatile organic solvent. Examples of volatile organic solventsthat are excluded from the manufacture of the present silicone hydrogelcontact lenses to remove an extractable component from polymerized lensbodies include primary alcohols, secondary alcohols, tertiary alcohols,or any combination thereof. Unlike commercially available siliconehydrogel contact lenses, the present silicone hydrogel contact lensesare only exposed to aqueous solutions that are free of volatile organicsolvents to remove an extractable component from the polymerized lensbodies. The aqueous solutions may contain non-volatile organicingredients, such as surfactants, wetting agents, anti-inflammatoryagents, anti-oxidants, stabilizers, extraction aids, and the like, solong as the aqueous solution does not contain a volatile organicsolvent. Thus, the present silicone hydrogel contact lenses areunderstood to be aqueous extracted contact lenses. As discussed herein,an aqueous extracted contact lens is chemically and physically differentand distinct from an organic solvent extracted contact lens.

The present silicone hydrogel contact lenses comprise aqueous extractedlens bodies. The aqueous extracted lens bodies each have an anteriorsurface and an opposing posterior surface, the posterior surface beingthe surface adjacent to the corneal epithelium of an eye on which thelens body is located. The anterior surfaces of the lens bodies of thepresent disclosure are associated with a reduced incidence ofnon-wetting spots compared to other daily disposable silicone hydrogelcontact lenses. Based on studies, other commercially available dailydisposable silicone hydrogel contact lenses, when worn on a populationof contact lens wearers' eyes and observed under conventional slit lampexaminations, have non-wetting spots on at least 5% of the lenses. Forsome batches of commercially available daily disposable siliconehydrogel contact lenses, the incidence of non-wetting spots present onthe contact lenses has been observed to be over 20%. In comparison,using the same examination techniques, the silicone hydrogel contactlenses disclosed herein have non-wetting spots on less than 5% of thelenses worn on patient's eyes.

Thus, the inventors have invented new silicone hydrogel contact lenseswith desirable clinical surface wettabilities without requiring the useof volatile organic solvents to remove extractable material from thelens bodies during the manufacture thereof. In addition, the surfacewettabilities have been achieved without requiring a plasma treatment ofthe polymerized lens product, or a polymeric internal wetting agent,such as polyvinyl pyrrolidone (PVP) in the contact lens formulation. Itcan be understood that a problem of producing silicone hydrogel contactlenses with clinically desirable surface wettabilities and withoutextracting the lens bodies with a volatile organic solvent has now beenidentified and solved.

Thus, silicone hydrogel contact lenses are produced without usingvolatile organic solvents to extract materials from the polymerizedcontact lens bodies, and instead are washed with aqueous liquids. Thesilicone hydrogel contact lenses so produced have ophthalmicallywettable lens surfaces such that less than five percent of a batch oftwenty or more such silicone hydrogel contact lenses have visuallyidentifiable non-wetting spots when the contact lenses are located oneyes of subjects.

In accordance with the present disclosure, a method of manufacturing abatch of silicone hydrogel contact lenses comprises providingpolymerized silicone hydrogel contact lens bodies in contact lens moldassemblies. A single polymerized silicone hydrogel contact lens body isprovided in a single contact lens mold assembly. Each contact lens moldassembly comprises a first mold section (front surface mold section)having a concave optical surface for forming an anterior surface of thesilicone hydrogel contact lens body and a second mold section (backsurface mold section) having a convex optical surface for forming aposterior surface of the silicone hydrogel contact lens body. The firstmold section and second mold section are coupled together to form thecontact lens mold assembly.

The method comprises separating the polymerized silicone hydrogelcontact lens bodies from the contact lens mold assemblies to producedelensed contact lens bodies. This can be accomplished by separating thefirst mold section and the second mold section from each other so thatthe polymerized silicone hydrogel contact lens body remains adhered toone of the mold sections. The polymerized silicone hydrogel contact lensbody can then be mechanically separated from the mold section withoutliquid, or can be separated from the mold section using a liquid, suchas by immersing the mold section and lens in a volume of liquid, or bysoaking the mold until the lens floats off the mold, or by applying aliquid to the mold section to soak the lens body, or by dissolving themold in a liquid.

The method further comprises washing the delensed contact lens bodieswith an aqueous liquid free of volatile organic solvent to producewashed contact lenses. These washed contact lenses can be understood tobe aqueous extracted contact lenses.

The washed contact lenses are then sterilized in sealed contact lenspackages, such as by autoclaving the lenses in the sealed packages.

In one example, the silicone hydrogel contact lenses are not contactedby a liquid comprising a volatile organic solvent during any step of themanufacturing process (i.e., all liquids which contact the lens duringmanufacturing are free of a volatile organic solvent).

In one example, the method of manufacturing a batch of silicone hydrogelcontact lenses of the present disclosure is a method comprising:providing polymerized silicone hydrogel contact lens bodies in contactlens mold assemblies, wherein a single polymerized silicone hydrogelcontact lens body is provided in a single contact lens mold assembly,and each contact lens mold assembly comprises a first mold sectionhaving a concave optical surface for forming an anterior surface of thesilicone hydrogel contact lens body and a second mold section having aconvex optical surface for forming a posterior surface of the siliconehydrogel contact lens body, and the first mold section and second moldsection are coupled together; separating the polymerized siliconehydrogel contact lens bodies from the contact lens mold assemblies toproduce delensed contact lens bodies; washing the delensed contact lensbodies with an aqueous liquid free of volatile organic solvent toproduce washed contact lenses; and sterilizing the washed contact lensesin sealed contact lens packages; wherein the batch so manufacturedcomprises at least twenty silicone hydrogel contact lenses, and theanterior surfaces of the sterilized contact lenses have clinicallyacceptable surface wettabilities such that less than five percent of thesilicone hydrogel contact lenses have visually identifiable non-wettingspots when located on eyes of subjects, and wherein the non-wettingspots are discontinuities of the contact lens wearer's pre-lens tearfilm present on the anterior surface of the contact lens, and arevisually identifiable during a slit lamp examination at a totalmagnification from about 6× to about 70×.

The batch so manufactured comprises at least twenty silicone hydrogelcontact lenses, and the anterior surfaces of the sterilized contactlenses have clinically acceptable surface wettabilities. As used herein,such clinically acceptable surface wettabilities are based on less thanfive percent of the silicone hydrogel contact lenses having visuallyidentifiable non-wetting spots when located on eyes of subjects orpeople. The non-wetting spots are discontinuities of the contact lenswearer's pre-lens tear film present on the anterior surface of thecontact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×, orusing other conventional eye and lens examination techniques, such asthose disclosed in U.S. Pat. No. 4,747,683, which provide techniques fordetermining the in vivo wettability of a contact lens by adding a dye,such as fluorescein, to the tear fluid to visualize the thin prelenstear film.

Another example of the present disclosure relates to a batch of siliconehydrogel contact lenses so produced.

In one example, a batch of silicone hydrogel contact lenses inaccordance with the present disclosure is a batch comprising: at leasttwenty silicone hydrogel contact lenses, each silicone hydrogel contactlens of the batch being an aqueous extracted silicone hydrogel contactlens comprising an anterior surface and an opposing posterior surface,the posterior surface dimensioned (sized and shaped) for placementagainst a subject's eye; the anterior surface of each of the aqueousextracted contact lenses having a clinically acceptable surfacewettability, such that less than five percent of the batch of siliconehydrogel contact lenses has visually identifiable non-wetting spots whenlocated on eyes of subject; wherein the non-wetting spots arediscontinuities of the contact lens wearer's pre-lens tear film presenton the anterior surface of the lens body, and are visually identifiableduring a slit lamp examination at a total magnification from about 6× toabout 70×.

Additional examples of the present disclosure are set forth in theclaims. For example, some of the present methods and batches of siliconehydrogel contact lenses relate to the use of certain polar resins, suchas polybutylene terephthalate (PBT), to form contact lens mold sectionsused to cast the silicone hydrogel contact lenses. Some of the presentmethods and batches of silicone hydrogel contact lenses relate to newcombinations of ingredients, such as siloxane monomers, hydrophilicmonomers, hydrophobic monomers, cross-linking agents, and the like whichsurprisingly provide ophthalmically compatible or wettable lenssurfaces, even when such polymerizable compositions or formulations arecast in contact lens mold assemblies made from non-polar resins, such aspolypropylene. These contact lenses with wettable surfaces are obtainedwithout exposing or contacting the polymerized lenses with volatileorganic solvents, and instead are washed with aqueous liquids.

Additional embodiments of the polymerizable compositions, presentlenses, lens products, batches of lenses, and methods of manufacturingcontact lenses will be apparent from the following description,Examples, and claims. As can be appreciated from the foregoing andfollowing description, each and every feature described herein, and eachand every combination of two or more of such features, and each andevery combination of one or more values defining a range, are includedwithin the scope of the present invention provided that the featuresincluded in such a combination are not mutually inconsistent. Inaddition, any feature or combination of features or any value(s)defining a range may be specifically excluded from any embodiment of thepresent invention.

DETAILED DESCRIPTION

As described herein, it has now been discovered that silicone hydrogelcontact lenses can be produced with clinically acceptable surfacewettabilities without contacting the polymerized silicone hydrogelcontact lenses with one or more volatile organic solvents, especiallyduring processing steps between separating the lenses from moldassemblies and packaging the lenses. Such clinically acceptable siliconehydrogel contact lenses can be produced without requiring a surfacetreatment of a polymerized lens body to achieve the wettability, withoutincluding a hydrophilic polymer in the formulation used to make thecontact lenses, or without using an organic diluent in the formulationto reduce phase separation of hydrophobic and hydrophilic components ofthe formulation.

In accordance with the present disclosure, methods of manufacturing abatch of silicone hydrogel contact lenses are provided. The methodscomprise a step of providing polymerized silicone hydrogel contact lensbodies in contact lens mold assemblies. Each contact lens mold assemblycomprises a first mold section and a second mold section. The first andsecond mold section are coupled together to provide a contact lensshaped cavity between the first and second mold section. The first moldsection has a concave optical surface, which forms the anterior surfaceof the silicone hydrogel contact lens body. The first mold section maythus be understood to be a front surface mold section. The second moldsection has a convex optical surface, which forms the posterior surfaceof the silicone hydrogel contact lens body. The second mold section maythus be understood to be a rear surface mold section.

The contact lenses so provided can be provided by forming thepolymerized silicone hydrogel contact lens bodies in the contact lensmold assemblies by polymerizing the contact lens formulation orpolymerizable composition to form the silicone hydrogel contact lensbody. The polymerization can occur by exposing the contact lens moldassemblies to thermal radiation, ultraviolet radiation, visible light,and the like.

The providing step can also be understood to be a step in whichpolymerized silicone hydrogel contact lens bodies located in the contactlens mold assemblies are provided to a separate entity for furtherprocessing, such as separating the lens bodies from the mold assembliesand washing and packaging the separated lens bodies. Thus, it ispossible for a single manufacturer to form polymerized silicone hydrogelcontact lens bodies, and further process them to form packaged siliconehydrogel contact lenses, or the manufacturer can form the polymerizedsilicone hydrogel contact lens bodies and provide them to othercompanies for further processing to sell the contact lenses under theirown label or brand.

In the present methods, the polymerized silicone hydrogel contact lensbodies are separated from the contact lens mold assemblies to producedelensed contact lens bodies. As discussed herein in more detail, suchmethods may further comprise separating the first mold section and thesecond mold section such that the polymerized silicone hydrogel contactlens body remains attached to one of the mold sections. The polymerizedsilicone hydrogel contact lens can then be mechanically separated fromthe mold section without using a liquid, or can be contacted with aliquid to release the lens body from the mold section.

The delensed contact lens bodies are then washed with an aqueous liquid.The washing can be effective to remove dust or debris from the lens, toextract materials from the lens, to hydrate the lens, or any combinationthereof. The aqueous liquid is free of a volatile organic solvent. Theaqueous liquid can be deionized water. The aqueous liquid can be asolution of deionized water comprising a salt, wherein the aqueousliquid is free of a volatile organic solvent. The aqueous liquid can bea solution of deionized water comprising a buffering agent and having aparticular desired pH, wherein the aqueous liquid is free of a volatileorganic solvent. The aqueous liquid can be a solution of deionized watercomprising a surfactant, wherein the aqueous liquid is free of anorganic solvent. The aqueous liquid can be a solution of deionized watercomprising an ophthalmically acceptable ingredient in an amounteffective to reduce lens distortion during processing, wherein theaqueous liquid is free of a volatile organic solvent. The aqueous liquidcan be a solution of deionized water comprising an ophthalmicallyacceptable ingredient in an amount effective to increase a level ofextractable material removed from the lens during washing, wherein theaqueous liquid is free of an organic solvent. After washing, washedcontact lenses are produced.

The washed contact lenses are placed in contact lens packages, such asblister packs or vials, which are then sealed, and sterilized, such asby autoclaving, as understood by persons of ordinary skill in the art.

In one example, the silicone hydrogel contact lenses are not contactedby a liquid comprising a volatile organic solvent during any step of themanufacturing process (i.e., all liquids which contact the lens duringmanufacturing are free of a volatile organic solvent).

One example of a method of manufacturing a batch of silicone hydrogelcontact lenses of the present disclosure is a method comprising:providing polymerized silicone hydrogel contact lens bodies in contactlens mold assemblies, wherein a single polymerized silicone hydrogelcontact lens body is provided in a single contact lens mold assembly,and each contact lens mold assembly comprises a first mold sectionhaving a concave optical surface for forming an anterior surface of thesilicone hydrogel contact lens body and a second mold section having aconvex optical surface for forming a posterior surface of the siliconehydrogel contact lens body, and the first mold section and second moldsection are coupled together; separating the polymerized siliconehydrogel contact lens bodies from the contact lens mold assemblies toproduce delensed contact lens bodies; washing the delensed contact lensbodies with an aqueous liquid free of volatile organic solvent toproduce washed contact lenses; and sterilizing the washed contact lensesin sealed contact lens packages; wherein the silicone hydrogel contactlenses are not contacted by a liquid comprising a volatile organicsolvent during any step of the manufacturing process, and the batch somanufactured comprises at least twenty silicone hydrogel contact lenses,and the anterior surfaces of the sterilized contact lenses haveclinically acceptable surface wettabilities such that less than fivepercent of the silicone hydrogel contact lenses have visuallyidentifiable non-wetting spots when located on eyes of subjects, andwherein the non-wetting spots are discontinuities of the contact lenswearer's pre-lens tear film present on the anterior surface of thecontact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×.

One example of a batch of silicone hydrogel contact lenses in accordancewith the present disclosure is a batch comprising: at least twentysilicone hydrogel contact lenses, each silicone hydrogel contact lens ofthe batch being an aqueous extracted silicone hydrogel contact lens notcontacted by a liquid comprising a volatile organic solvent during anystep of the manufacturing process, each contact lens comprising ananterior surface and an opposing posterior surface, the posteriorsurface dimensioned (sized and shaped) for placement against a subject'seye; the anterior surface of each of the aqueous extracted contactlenses having a clinically acceptable surface wettability, such thatless than five percent of the batch of silicone hydrogel contact lenseshas visually identifiable non-wetting spots when located on eyes ofsubject; wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the lens body, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×.

The batch of contact lenses so manufactured comprises at least twentysilicone hydrogel contact lenses. However, typically, batches will begreater than twenty, and may comprise at least one hundred, at least onethousand, or at least ten thousand silicone hydrogel contact lenses. Asdisclosed herein, the anterior surfaces of the sterilized siliconehydrogel contact lenses have clinically acceptable surface wettabilitiessuch that less than five percent of the silicone hydrogel contact lenseshave visually identifiable non-wetting spots when located on eyes ofsubjects or people. The non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film and are present on the anteriorsurface of the contact lens. The non-wetting spots are visuallyidentifiable during a slit lamp examination by an eye care practitionerat a total magnification from about 6× to about 70×. Such examinationtechniques to determine the presence or absence of non-wetting spots areconvention and understood by persons of ordinary skill in the art.

In some of the methods, at least one of the first mold section or thesecond mold section comprises a polar resin having a polarity from 1% to7%. In some methods, both the first and second mold section comprisessuch a polar resin. One example of a polar resin that is useful in thepresent methods includes resins formed from polybutylene terephthalate(PBT). In some additional examples, the polar resins, such as PBT, usedto form the first and second mold sections have a flexural modulus lessthan 3800 MPa.

One example of a method of manufacturing a batch of silicone hydrogelcontact lenses of the present disclosure is a method comprising:providing polymerized silicone hydrogel contact lens bodies in contactlens mold assemblies, wherein a single polymerized silicone hydrogelcontact lens body is provided in a single contact lens mold assembly,and each contact lens mold assembly comprises a first mold sectionhaving a concave optical surface for forming an anterior surface of thesilicone hydrogel contact lens body and a second mold section having aconvex optical surface for forming a posterior surface of the siliconehydrogel contact lens body, at least one of the first mold section orthe second mold section comprises a polar resin having a polarity from1% to 7%, and the first mold section and second mold section are coupledtogether; separating the polymerized silicone hydrogel contact lensbodies from the contact lens mold assemblies to produce delensed contactlens bodies; washing the delensed contact lens bodies with an aqueousliquid free of volatile organic solvent to produce washed contactlenses; and sterilizing the washed contact lenses in sealed contact lenspackages; wherein the batch so manufactured comprises at least twentysilicone hydrogel contact lenses, and the anterior surfaces of thesterilized contact lenses have clinically acceptable surfacewettabilities such that less than five percent of the silicone hydrogelcontact lenses have visually identifiable non-wetting spots when locatedon eyes of subjects, and wherein the non-wetting spots arediscontinuities of the contact lens wearer's pre-lens tear film presenton the anterior surface of the contact lens, and are visuallyidentifiable during a slit lamp examination at a total magnificationfrom about 6× to about 70×.

One example of a batch of silicone hydrogel contact lenses in accordancewith the present disclosure is a batch comprising: at least twentysilicone hydrogel contact lenses, each silicone hydrogel contact lens ofthe batch being molded in a single contact lens mold assembly, eachcontact lens mold assembly comprising a first mold section having aconcave optical surface for forming an anterior surface of the siliconehydrogel contact lens body and a second mold section having a convexoptical surface for forming a posterior surface of the silicone hydrogelcontact lens body, at least one of the first mold section or the secondmold section comprising a polar resin having a polarity from 1% to 7%,and each silicone hydrogel contact lens being an aqueous extractedsilicone hydrogel contact lens comprising an anterior surface and anopposing posterior surface, the posterior surface dimensioned (sized andshaped) for placement against a subject's eye; the anterior surface ofeach of the aqueous extracted contact lenses having a clinicallyacceptable surface wettability, such that less than five percent of thebatch of silicone hydrogel contact lenses has visually identifiablenon-wetting spots when located on eyes of subject; wherein thenon-wetting spots are discontinuities of the contact lens wearer'spre-lens tear film present on the anterior surface of the lens body, andare visually identifiable during a slit lamp examination at a totalmagnification from about 6× to about 70×.

As described herein, the polymerized contact lens bodies can be obtainedby polymerizing a polymerizable composition in a contact lens moldassembly using thermal radiation, or ultraviolet radiation, or both.Typically, if thermal radiation is used, the polymerizable compositionwill include a thermal initiator. If ultraviolet radiation is used, thepolymerizable composition will include an ultraviolet initiator. Thecuring times can vary depending on the silicone hydrogel contact lensbeing produced and frequently range from 20 minutes to 4 hours. In oneexample, a curing time of the polymerizable composition can be less than20 minutes. In another example, a curing time of the polymerizablecomposition can be at least 20 minutes. In another example, the curingtime can be less than 3 hours. In yet another example, the curing timecan be more than 3 hours.

In some methods, the curing can be achieved by providing a curingprofile where a certain temperature or certain light intensity isprovided for a certain amount of time before changing to anothertemperature or intensity for another amount of time.

In any of the present methods, each polymerized silicone hydrogelcontact lens body is obtained by polymerizing a polymerizablecomposition. Generally, the polymerizable composition comprises at leastone siloxane monomer, at least one hydrophilic monomer, at least onehydrophobic monomer, and at least one cross-linking agent. For example,polymerizable compositions may comprise a first siloxane monomer, asecond siloxane monomer, one or more hydrophilic monomers, one or morehydrophobic monomers, and one or more cross-linking agents. Additionaldetails and various examples of the ingredients of the polymerizablecompositions and the amounts and relationship among the ingredients aredescribed herein. As one example, many of the present polymerizablecompositions are free of a diluent, or free of a hydrophilic polymer, orboth.

One example of a method of manufacturing a batch of silicone hydrogelcontact lenses of the present disclosure is a method comprising:providing polymerized silicone hydrogel contact lens bodies in contactlens mold assemblies, the polymerized silicone hydrogel contact lensbodies being the reaction product of a polymerizable compositioncomprising a first siloxane monomer, a second siloxane monomer, at leastone hydrophilic monomer, at least one hydrophobic monomer, and at leastone cross-linking agent, wherein a single polymerized silicone hydrogelcontact lens body is provided in a single contact lens mold assembly,and each contact lens mold assembly comprises a first mold sectionhaving a concave optical surface for forming an anterior surface of thesilicone hydrogel contact lens body and a second mold section having aconvex optical surface for forming a posterior surface of the siliconehydrogel contact lens body, and the first mold section and second moldsection are coupled together; separating the polymerized siliconehydrogel contact lens bodies from the contact lens mold assemblies toproduce delensed contact lens bodies; washing the delensed contact lensbodies with an aqueous liquid free of volatile organic solvent toproduce washed contact lenses; and sterilizing the washed contact lensesin sealed contact lens packages; wherein the batch so manufacturedcomprises at least twenty silicone hydrogel contact lenses, and theanterior surfaces of the sterilized contact lenses have clinicallyacceptable surface wettabilities such that less than five percent of thesilicone hydrogel contact lenses have visually identifiable non-wettingspots when located on eyes of subjects, and wherein the non-wettingspots are discontinuities of the contact lens wearer's pre-lens tearfilm present on the anterior surface of the contact lens, and arevisually identifiable during a slit lamp examination at a totalmagnification from about 6× to about 70×.

Another example of a method of manufacturing a batch of siliconehydrogel contact lenses of the present disclosure is a methodcomprising: providing polymerized silicone hydrogel contact lens bodiesin contact lens mold assemblies, the polymerized silicone hydrogelcontact lens bodies being the reaction product of a polymerizablecomposition comprising a first siloxane monomer, a second siloxanemonomer, at least one hydrophilic monomer, at least one hydrophobicmonomer, and at least one cross-linking agent, wherein the polymerizablecomposition is free of a diluent, or free of a hydrophilic polymer, orboth, and wherein a single polymerized silicone hydrogel contact lensbody is provided in a single contact lens mold assembly, and eachcontact lens mold assembly comprises a first mold section having aconcave optical surface for forming an anterior surface of the siliconehydrogel contact lens body and a second mold section having a convexoptical surface for forming a posterior surface of the silicone hydrogelcontact lens body, and the first mold section and second mold sectionare coupled together; separating the polymerized silicone hydrogelcontact lens bodies from the contact lens mold assemblies to producedelensed contact lens bodies; washing the delensed contact lens bodieswith an aqueous liquid free of volatile organic solvent to producewashed contact lenses; and sterilizing the washed contact lenses insealed contact lens packages; wherein the batch so manufacturedcomprises at least twenty silicone hydrogel contact lenses, and theanterior surfaces of the sterilized contact lenses have clinicallyacceptable surface wettabilities such that less than five percent of thesilicone hydrogel contact lenses have visually identifiable non-wettingspots when located on eyes of subjects, and wherein the non-wettingspots are discontinuities of the contact lens wearer's pre-lens tearfilm present on the anterior surface of the contact lens, and arevisually identifiable during a slit lamp examination at a totalmagnification from about 6× to about 70×.

One example of a batch of silicone hydrogel contact lenses in accordancewith the present disclosure is a batch comprising: at least twentypolymerized silicone hydrogel contact lenses, the polymerized siliconehydrogel contact lenses being the reaction product of a polymerizablecomposition comprising a first siloxane monomer, a second siloxanemonomer, at least one hydrophilic monomer, at least one hydrophobicmonomer, and at least one cross-linking agent, each silicone hydrogelcontact lens of the batch being an aqueous extracted silicone hydrogelcontact lens comprising an anterior surface and an opposing posteriorsurface, the posterior surface dimensioned (sized and shaped) forplacement against a subject's eye; the anterior surface of each of theaqueous extracted contact lenses having a clinically acceptable surfacewettability, such that less than five percent of the batch of siliconehydrogel contact lenses has visually identifiable non-wetting spots whenlocated on eyes of subject; wherein the non-wetting spots arediscontinuities of the contact lens wearer's pre-lens tear film presenton the anterior surface of the lens body, and are visually identifiableduring a slit lamp examination at a total magnification from about 6× toabout 70×.

Another example of a batch of silicone hydrogel contact lenses inaccordance with the present disclosure is a batch comprising: at leasttwenty polymerized silicone hydrogel contact lenses, the polymerizedsilicone hydrogel contact lenses being the reaction product of apolymerizable composition comprising a first siloxane monomer, a secondsiloxane monomer, at least one hydrophilic monomer, at least onehydrophobic monomer, and at least one cross-linking agent, wherein thepolymerizable composition is free of a diluent, or free of a hydrophilicpolymer, or both, and each silicone hydrogel contact lens of the batchbeing an aqueous extracted silicone hydrogel contact lens comprising ananterior surface and an opposing posterior surface, the posteriorsurface dimensioned (sized and shaped) for placement against a subject'seye; the anterior surface of each of the aqueous extracted contactlenses having a clinically acceptable surface wettability, such thatless than five percent of the batch of silicone hydrogel contact lenseshas visually identifiable non-wetting spots when located on eyes ofsubject; wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the lens body, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×.

In some detail, the siloxane monomer(s) in the present polymerizablecompositions may be monofunctional or multifunctional, such asbifunctional or trifunctional. A monofunctional siloxane monomer has asingle polymerizable functional group, such as an acrylic group,methacrylic group, or vinyl group. A multifunctional siloxane monomerhas two or more such polymerizable functional groups. The polymerizablefunctional group(s) can be present on a side chain of the siloxanemonomer, on the main chain or backbone of the siloxane monomer, or bothon side chains and main chain for multifunctional siloxane monomers. Insome of the polymerizable compositions described herein, the firstsiloxane monomer is a monofunctional siloxane monomer, and the secondsiloxane monomer is a multifunctional siloxane monomer. In furtherexamples, the number average molecular weight of the first siloxanemonomer is less than 2,000 daltons, or less than 1,000 daltons, or from400 to 700 daltons. In examples containing a second multifunctionalsiloxane monomer, the second siloxane monomer has a number averagemolecular weight greater than 3,000 daltons. Some second siloxanemonomers have a number average molecular weight greater than 5,000daltons, or greater than 9,000 daltons. Frequently, the secondmultifunctional siloxane monomers have a number average molecular weightless than 20,000 daltons. The first siloxane monomer can be present inan amount from 20 to 45 unit parts, or from 25 to 40 unit parts or from27 to 35 unit parts of the polymerizable composition. Additional detailsof the siloxane monomer(s) useful in any of the present methods aredescribed herein.

One example of a method of manufacturing a batch of silicone hydrogelcontact lenses of the present disclosure is a method comprising:providing polymerized silicone hydrogel contact lens bodies in contactlens mold assemblies, the polymerized silicone hydrogel contact lensbodies being the reaction product of a polymerizable compositioncomprising a first siloxane monomer having a number average molecularweight of from 400 daltons to 700 daltons, a second siloxane monomerhaving a number average molecular weight of greater than 5,000 daltons,at least one hydrophilic monomer, at least one hydrophobic monomer, andat least one cross-linking agent, wherein a single polymerized siliconehydrogel contact lens body is provided in a single contact lens moldassembly, and each contact lens mold assembly comprises a first moldsection having a concave optical surface for forming an anterior surfaceof the silicone hydrogel contact lens body and a second mold sectionhaving a convex optical surface for forming a posterior surface of thesilicone hydrogel contact lens body, and the first mold section andsecond mold section are coupled together; separating the polymerizedsilicone hydrogel contact lens bodies from the contact lens moldassemblies to produce delensed contact lens bodies; washing the delensedcontact lens bodies with an aqueous liquid free of volatile organicsolvent to produce washed contact lenses; and sterilizing the washedcontact lenses in sealed contact lens packages; wherein the batch somanufactured comprises at least twenty silicone hydrogel contact lenses,and the anterior surfaces of the sterilized contact lenses haveclinically acceptable surface wettabilities such that less than fivepercent of the silicone hydrogel contact lenses have visuallyidentifiable non-wetting spots when located on eyes of subjects, andwherein the non-wetting spots are discontinuities of the contact lenswearer's pre-lens tear film present on the anterior surface of thecontact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×.

One example of a batch of silicone hydrogel contact lenses in accordancewith the present disclosure is a batch comprising: at least twentypolymerized silicone hydrogel contact lenses, the polymerized siliconehydrogel contact lenses being the reaction product of a polymerizablecomposition comprising a first siloxane monomer having a number averagemolecular weight of from 400 daltons to 700 daltons, a second siloxanemonomer having a number average molecular weight of greater than 5,000daltons, at least one hydrophilic monomer, at least one hydrophobicmonomer, and at least one cross-linking agent, each silicone hydrogelcontact lens of the batch being an aqueous extracted silicone hydrogelcontact lens comprising an anterior surface and an opposing posteriorsurface, the posterior surface dimensioned (sized and shaped) forplacement against a subject's eye; the anterior surface of each of theaqueous extracted contact lenses having a clinically acceptable surfacewettability, such that less than five percent of the batch of siliconehydrogel contact lenses has visually identifiable non-wetting spots whenlocated on eyes of subject; wherein the non-wetting spots arediscontinuities of the contact lens wearer's pre-lens tear film presenton the anterior surface of the lens body, and are visually identifiableduring a slit lamp examination at a total magnification from about 6× toabout 70×.

In some of the present methods, particular combinations of ingredientsare provided. For example, the present batches of silicone hydrogelcontact lenses with clinically acceptable surface wettabilities can bemanufactured by including at least one hydrophilic vinyl monomer and atleast one vinyl cross-linking agent in the polymerizable composition.Such vinyl monomers and vinyl cross-linking agents are distinguishedfrom methacrylate type monomers and methacrylate type cross-linkingagents based on their differing reactivity ratios, among other things.

One example of a method of manufacturing a batch of silicone hydrogelcontact lenses of the present disclosure is a method comprising:providing polymerized silicone hydrogel contact lens bodies in contactlens mold assemblies, the polymerized silicone hydrogel contact lensbodies being the reaction product of a polymerizable compositioncomprising a first siloxane monomer, a second siloxane monomer, at leastone hydrophilic vinyl-containing monomer, at least one hydrophobicmonomer, and at least one cross-linking agent, wherein a singlepolymerized silicone hydrogel contact lens body is provided in a singlecontact lens mold assembly, and each contact lens mold assemblycomprises a first mold section having a concave optical surface forforming an anterior surface of the silicone hydrogel contact lens bodyand a second mold section having a convex optical surface for forming aposterior surface of the silicone hydrogel contact lens body, and thefirst mold section and second mold section are coupled together;separating the polymerized silicone hydrogel contact lens bodies fromthe contact lens mold assemblies to produce delensed contact lensbodies; washing the delensed contact lens bodies with an aqueous liquidfree of volatile organic solvent to produce washed contact lenses; andsterilizing the washed contact lenses in sealed contact lens packages;wherein the batch so manufactured comprises at least twenty siliconehydrogel contact lenses, and the anterior surfaces of the sterilizedcontact lenses have clinically acceptable surface wettabilities suchthat less than five percent of the silicone hydrogel contact lenses havevisually identifiable non-wetting spots when located on eyes ofsubjects, and wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the contact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×.

Another example of a method of manufacturing a batch of siliconehydrogel contact lenses of the present disclosure is a methodcomprising: providing polymerized silicone hydrogel contact lens bodiesin contact lens mold assemblies, the polymerized silicone hydrogelcontact lens bodies being the reaction product of a polymerizablecomposition comprising a first siloxane monomer, a second siloxanemonomer, at least one hydrophilic vinyl-containing monomer, at least onehydrophobic monomer, and at least one vinyl-containing cross-linkingagent, wherein a single polymerized silicone hydrogel contact lens bodyis provided in a single contact lens mold assembly, and each contactlens mold assembly comprises a first mold section having a concaveoptical surface for forming an anterior surface of the silicone hydrogelcontact lens body and a second mold section having a convex opticalsurface for forming a posterior surface of the silicone hydrogel contactlens body, and the first mold section and second mold section arecoupled together; separating the polymerized silicone hydrogel contactlens bodies from the contact lens mold assemblies to produce delensedcontact lens bodies; washing the delensed contact lens bodies with anaqueous liquid free of volatile organic solvent to produce washedcontact lenses; and sterilizing the washed contact lenses in sealedcontact lens packages; wherein the batch so manufactured comprises atleast twenty silicone hydrogel contact lenses, and the anterior surfacesof the sterilized contact lenses have clinically acceptable surfacewettabilities such that less than five percent of the silicone hydrogelcontact lenses have visually identifiable non-wetting spots when locatedon eyes of subjects, and wherein the non-wetting spots arediscontinuities of the contact lens wearer's pre-lens tear film presenton the anterior surface of the contact lens, and are visuallyidentifiable during a slit lamp examination at a total magnificationfrom about 6× to about 70×.

Another example of a method of manufacturing a batch of siliconehydrogel contact lenses of the present disclosure is a methodcomprising: providing polymerized silicone hydrogel contact lens bodiesin contact lens mold assemblies, the polymerized silicone hydrogelcontact lens bodies being the reaction product of a polymerizablecomposition comprising a first siloxane monomer, a second siloxanemonomer, at least one hydrophilic amide monomer having one N-vinylgroup, at least one hydrophobic monomer, and at least one cross-linkingagent, wherein a single polymerized silicone hydrogel contact lens bodyis provided in a single contact lens mold assembly, and each contactlens mold assembly comprises a first mold section having a concaveoptical surface for forming an anterior surface of the silicone hydrogelcontact lens body and a second mold section having a convex opticalsurface for forming a posterior surface of the silicone hydrogel contactlens body, and the first mold section and second mold section arecoupled together; separating the polymerized silicone hydrogel contactlens bodies from the contact lens mold assemblies to produce delensedcontact lens bodies; washing the delensed contact lens bodies with anaqueous liquid free of volatile organic solvent to produce washedcontact lenses; and sterilizing the washed contact lenses in sealedcontact lens packages; wherein the batch so manufactured comprises atleast twenty silicone hydrogel contact lenses, and the anterior surfacesof the sterilized contact lenses have clinically acceptable surfacewettabilities such that less than five percent of the silicone hydrogelcontact lenses have visually identifiable non-wetting spots when locatedon eyes of subjects, and wherein the non-wetting spots arediscontinuities of the contact lens wearer's pre-lens tear film presenton the anterior surface of the contact lens, and are visuallyidentifiable during a slit lamp examination at a total magnificationfrom about 6× to about 70×.

Another example of a method of manufacturing a batch of siliconehydrogel contact lenses of the present disclosure is a methodcomprising: providing polymerized silicone hydrogel contact lens bodiesin contact lens mold assemblies, the polymerized silicone hydrogelcontact lens bodies being the reaction product of a polymerizablecomposition comprising a first siloxane monomer, a second siloxanemonomer, at least one hydrophilic amide monomer having one N-vinylgroup, at least one hydrophobic monomer, and at least onevinyl-containing cross-linking agent, wherein a single polymerizedsilicone hydrogel contact lens body is provided in a single contact lensmold assembly, and each contact lens mold assembly comprises a firstmold section having a concave optical surface for forming an anteriorsurface of the silicone hydrogel contact lens body and a second moldsection having a convex optical surface for forming a posterior surfaceof the silicone hydrogel contact lens body, and the first mold sectionand second mold section are coupled together; separating the polymerizedsilicone hydrogel contact lens bodies from the contact lens moldassemblies to produce delensed contact lens bodies; washing the delensedcontact lens bodies with an aqueous liquid free of volatile organicsolvent to produce washed contact lenses; and sterilizing the washedcontact lenses in sealed contact lens packages; wherein the batch somanufactured comprises at least twenty silicone hydrogel contact lenses,and the anterior surfaces of the sterilized contact lenses haveclinically acceptable surface wettabilities such that less than fivepercent of the silicone hydrogel contact lenses have visuallyidentifiable non-wetting spots when located on eyes of subjects, andwherein the non-wetting spots are discontinuities of the contact lenswearer's pre-lens tear film present on the anterior surface of thecontact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×.

Yet another example of a method of manufacturing a batch of siliconehydrogel contact lenses of the present disclosure is a methodcomprising: providing polymerized silicone hydrogel contact lens bodiesin contact lens mold assemblies, the polymerized silicone hydrogelcontact lens bodies being the reaction product of a polymerizablecomposition comprising a first siloxane monomer, a second siloxanemonomer, at least one hydrophilic vinyl-containing monomer, at least onehydrophobic monomer, and at least one cross-linking agent, wherein thepolymerizable composition is free of a diluent, or free of a hydrophilicpolymer, or both, and wherein a single polymerized silicone hydrogelcontact lens body is provided in a single contact lens mold assembly,and each contact lens mold assembly comprises a first mold sectionhaving a concave optical surface for forming an anterior surface of thesilicone hydrogel contact lens body and a second mold section having aconvex optical surface for forming a posterior surface of the siliconehydrogel contact lens body, and the first mold section and second moldsection are coupled together; separating the polymerized siliconehydrogel contact lens bodies from the contact lens mold assemblies toproduce delensed contact lens bodies; washing the delensed contact lensbodies with an aqueous liquid free of volatile organic solvent toproduce washed contact lenses; and sterilizing the washed contact lensesin sealed contact lens packages; wherein the batch so manufacturedcomprises at least twenty silicone hydrogel contact lenses, and theanterior surfaces of the sterilized contact lenses have clinicallyacceptable surface wettabilities such that less than five percent of thesilicone hydrogel contact lenses have visually identifiable non-wettingspots when located on eyes of subjects, and wherein the non-wettingspots are discontinuities of the contact lens wearer's pre-lens tearfilm present on the anterior surface of the contact lens, and arevisually identifiable during a slit lamp examination at a totalmagnification from about 6× to about 70×.

On example of a batch of silicone hydrogel contact lenses in accordancewith the present disclosure is a batch comprising: at least twentypolymerized silicone hydrogel contact lenses, the polymerized siliconehydrogel contact lenses being the reaction product of a polymerizablecomposition comprising a first siloxane monomer, a second siloxanemonomer, at least one hydrophilic vinyl-containing monomer, at least onehydrophobic monomer, and at least one cross-linking agent, each siliconehydrogel contact lens of the batch being an aqueous extracted siliconehydrogel contact lens comprising an anterior surface and an opposingposterior surface, the posterior surface dimensioned (sized and shaped)for placement against a subject's eye; the anterior surface of each ofthe aqueous extracted contact lenses having a clinically acceptablesurface wettability, such that less than five percent of the batch ofsilicone hydrogel contact lenses has visually identifiable non-wettingspots when located on eyes of subject; wherein the non-wetting spots arediscontinuities of the contact lens wearer's pre-lens tear film presenton the anterior surface of the lens body, and are visually identifiableduring a slit lamp examination at a total magnification from about 6× toabout 70×.

Another example of a batch of silicone hydrogel contact lenses inaccordance with the present disclosure is a batch comprising: at leasttwenty polymerized silicone hydrogel contact lenses, the polymerizedsilicone hydrogel contact lenses being the reaction product of apolymerizable composition comprising a first siloxane monomer, a secondsiloxane monomer, at least one hydrophilic vinyl-containing monomer, atleast one hydrophobic monomer, and at least one vinyl-containingcross-linking agent, each silicone hydrogel contact lens of the batchbeing an aqueous extracted silicone hydrogel contact lens comprising ananterior surface and an opposing posterior surface, the posteriorsurface dimensioned (sized and shaped) for placement against a subject'seye; the anterior surface of each of the aqueous extracted contactlenses having a clinically acceptable surface wettability, such thatless than five percent of the batch of silicone hydrogel contact lenseshas visually identifiable non-wetting spots when located on eyes ofsubject; wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the lens body, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×.

Another example of a batch of silicone hydrogel contact lenses inaccordance with the present disclosure is a batch comprising: at leasttwenty polymerized silicone hydrogel contact lenses, the polymerizedsilicone hydrogel contact lenses being the reaction product of apolymerizable composition comprising a first siloxane monomer, a secondsiloxane monomer, at least one hydrophilic amide monomer having oneN-vinyl group, at least one hydrophobic monomer, and at least onecross-linking agent, each silicone hydrogel contact lens of the batchbeing an aqueous extracted silicone hydrogel contact lens comprising ananterior surface and an opposing posterior surface, the posteriorsurface dimensioned (sized and shaped) for placement against a subject'seye; the anterior surface of each of the aqueous extracted contactlenses having a clinically acceptable surface wettability, such thatless than five percent of the batch of silicone hydrogel contact lenseshas visually identifiable non-wetting spots when located on eyes ofsubject; wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the lens body, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×.

Yet another example of a batch of silicone hydrogel contact lenses inaccordance with the present disclosure is a batch comprising: at leasttwenty polymerized silicone hydrogel contact lenses, the polymerizedsilicone hydrogel contact lenses being the reaction product of apolymerizable composition comprising a first siloxane monomer, a secondsiloxane monomer, at least one hydrophilic vinyl-containing monomer, atleast one hydrophobic monomer, and at least one cross-linking agent,wherein the polymerizable composition is free of a diluent, or free of ahydrophilic polymer, or both, and each silicone hydrogel contact lens ofthe batch being an aqueous extracted silicone hydrogel contact lenscomprising an anterior surface and an opposing posterior surface, theposterior surface dimensioned (sized and shaped) for placement against asubject's eye; the anterior surface of each of the aqueous extractedcontact lenses having a clinically acceptable surface wettability, suchthat less than five percent of the batch of silicone hydrogel contactlenses has visually identifiable non-wetting spots when located on eyesof subject; wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the lens body, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×.

In any of the present methods, the batch of sterilized silicone hydrogelcontact lenses has an average diameter (i.e., average of each chorddiameter for each silicone hydrogel contact lens or representativepopulation of silicone hydrogel contact lenses) that is at least 20%greater than the average diameter of the same batch of silicone hydrogelcontact lens bodies prior to the washing step of the present methods.Thus, the present silicone hydrogel contact lenses are produced at acertain size in a dry state, and after washing, the contact lenses haveswollen to their final size, which is at least 20% greater than theirsize in the dry state. This is in contrast to silicone hydrogel contactlenses that are produced with volatile organic solvent extraction steps.For example, in such silicone hydrogel contact lenses, the dry lensesare produced at a size that is substantially equal, and less than 20%different, than their final hydrated size. Thus, when such dry lensesare contacted with a volatile organic solvent, such as ethanol and thelike, the individual contact lenses will swell to approximately twicetheir dry size, and then by removing the alcohol with aqueous solutionsto produce a hydrated contact lens, the hydrated contact lens size hasreturned to its original size, within specified target dimensions.

In any of the present methods in accordance with the present disclosure,silicone hydrogel contact lenses with clinically desirable propertiesare manufactured. For example, each of the sterilized silicone hydrogelcontact lenses has an oxygen permeability of at least 55 barrers, or anequilibrium water content from about 30% wt/wt to about 70% wt/wt, or atensile modulus from about 0.2 MPa to about 0.9 MPa, or any combinationthereof. In some examples, each of the sterilized silicone hydrogelcontact lenses has an oxygen permeability of at least 55 barrers, or anequilibrium water content from about 30% wt/wt to about 70% wt/wt, and atensile modulus from about 0.2 MPa to about 0.9 MPa.

Practicing the present methods results in the manufacture of a batch ofsilicone hydrogel contact lenses. The batch, as described herein,comprises at least twenty silicone hydrogel contact lenses, although thebatch can include more. Each silicone hydrogel contact lens of the batchis an aqueous extracted silicone hydrogel contact lens (e.g., it has notbeen washed or extracted with a volatile organic solvent). Each siliconehydrogel contact lens comprises an anterior surface and an opposingposterior surface. The posterior surface is dimensioned, such as beingsized and shaped, for placement against a subject's eye. The anteriorsurface of each of the aqueous extracted contact lenses has a clinicallyacceptable surface wettability, such that less than five percent of thebatch of silicone hydrogel contact lenses has visually identifiablenon-wetting spots when located on eyes of subjects. As described herein,the non-wetting spots are discontinuities of the contact lens wearer'spre-lens tear film present on the anterior surface of the lens, and arevisually identifiable during a slit lamp examination at a totalmagnification from about 6× to about 70×.

In some examples, the batch of silicone hydrogel contact lenses is acast molded silicone hydrogel contact lens without a plasma surfacetreatment or a polymeric internal wetting agent that is provided byincluding a hydrophilic polymer in a polymerizable composition used toform the silicone hydrogel contact lens. A cast molded contact lens isunderstood to be a contact lens polymerized from a polymerizablecomposition in a contact lens mold assembly comprising a first moldsection and second mold section coupled together, as described herein.

As described herein, certain examples of the present silicone hydrogelcontact lenses batches are cast molded between a first mold section anda second mold section formed from a polar resin having a polarity fromabout 1% to about 7%. In certain examples, the polar resin ispolybutylene terephthalate (PBT).

One example of a method of manufacturing a batch of silicone hydrogelcontact lenses of the present disclosure is a method comprising:providing polymerized silicone hydrogel contact lens bodies in contactlens mold assemblies, wherein a single polymerized silicone hydrogelcontact lens body is provided in a single contact lens mold assembly,and each contact lens mold assembly comprises a first mold sectionhaving a concave optical surface for forming an anterior surface of thesilicone hydrogel contact lens body and a second mold section having aconvex optical surface for forming a posterior surface of the siliconehydrogel contact lens body, at least one of the first mold section orthe second mold section comprises polybutylene terephthalate (PBT), andthe first mold section and second mold section are coupled together;separating the polymerized silicone hydrogel contact lens bodies fromthe contact lens mold assemblies to produce delensed contact lensbodies; washing the delensed contact lens bodies with an aqueous liquidfree of volatile organic solvent to produce washed contact lenses; andsterilizing the washed contact lenses in sealed contact lens packages;wherein the batch so manufactured comprises at least twenty siliconehydrogel contact lenses, and the anterior surfaces of the sterilizedcontact lenses have clinically acceptable surface wettabilities suchthat less than five percent of the silicone hydrogel contact lenses havevisually identifiable non-wetting spots when located on eyes ofsubjects, and wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the contact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×.

One example of a batch of silicone hydrogel contact lenses in accordancewith the present disclosure is a batch comprising: at least twentysilicone hydrogel contact lenses, each silicone hydrogel contact lens ofthe batch being molded in a single contact lens mold assembly, eachcontact lens mold assembly comprising a first mold section having aconcave optical surface for forming an anterior surface of the siliconehydrogel contact lens body and a second mold section having a convexoptical surface for forming a posterior surface of the silicone hydrogelcontact lens body, at least one of the first mold section or the secondmold section comprising polybutylene terephthalate (PBT), and eachsilicone hydrogel contact lens being an aqueous extracted siliconehydrogel contact lens comprising an anterior surface and an opposingposterior surface, the posterior surface dimensioned (sized and shaped)for placement against a subject's eye; the anterior surface of each ofthe aqueous extracted contact lenses having a clinically acceptablesurface wettability, such that less than five percent of the batch ofsilicone hydrogel contact lenses has visually identifiable non-wettingspots when located on eyes of subject; wherein the non-wetting spots arediscontinuities of the contact lens wearer's pre-lens tear film presenton the anterior surface of the lens body, and are visually identifiableduring a slit lamp examination at a total magnification from about 6× toabout 70×.

Any of the present batches may comprise silicone hydrogel contact lensesin which each contact lens comprises a polymeric component and a liquidcomponent. The polymeric component comprises units of at least onesiloxane, units of at least one hydrophilic monomer, units of at leastone hydrophobic monomer, and units of at least one cross-linking agent.In some examples, the polymeric component comprises units of at leastone siloxane having one or more functional acrylic groups, and units ofone or more hydrophilic monomers having one or more functionalnon-acrylic vinyl groups.

Any of the present batches may comprise silicone hydrogel contact lensesin which each contact lens has an oxygen permeability of at least 55barrers, or an equilibrium water content from about 30% wt/wt to about70% wt/wt, or a tensile modulus from about 0.2 MPa to about 0.9 MPa, orany combination thereof. In some examples, each contact lens has anoxygen permeability of at least 55 barrers, or an equilibrium watercontent from about 30% wt/wt to about 70% wt/wt, and a tensile modulusfrom about 0.2 MPa to about 0.9 MPa.

In any of the present batches of silicone hydrogel contact lenses, eachsilicone hydrogel contact lens is provided in a sterilized contact lenspackaging solution. In certain examples, each contact lens can have awet extractable content less than 10% (wt/wt), as described herein.

Additional details of the present silicone hydrogel contact lenses,batches of silicone hydrogel contact lenses, and methods ofmanufacturing will now be described.

In some examples, the present silicone hydrogel contact lenses areproduced from polymerizable compositions comprising a first siloxanemonomer represented by formula (1):

wherein m of formula (1) represents one integer from 3 to 10, n offormula (1) represents one integer from 1 to 10, R¹ of formula (1) is analkyl group having from 1 to 4 carbon atoms, and each R² of formula (1)is independently either a hydrogen atom or a methyl group; and a secondsiloxane monomer having more than one polymerizable functional group andhaving a number average molecular weight of at least 3,000 daltons, suchas, for example, a number average molecular weight of at least 5,000daltons, in the polymerizable composition. The first siloxane monomerand the second siloxane monomer are present in the polymerizablecomposition at a ratio of at least 2:1 based on unit parts by weight.

One example of a method of manufacturing a batch of silicone hydrogelcontact lenses of the present disclosure is a method comprising:providing polymerized silicone hydrogel contact lens bodies in contactlens mold assemblies, the polymerized silicone hydrogel contact lensbodies being the reaction product of a polymerizable compositioncomprising a first siloxane monomer represented by formula (1):

wherein m of formula (1) represents one integer from 3 to 10, n offormula (1) represents one integer from 1 to 10, R¹ of formula (1) is analkyl group having from 1 to 4 carbon atoms, and each R² of formula (1)is independently either a hydrogen atom or a methyl group, at least onehydrophilic vinyl-containing monomer, a second siloxane monomer havingmore than one polymerizable functional group and having a number averagemolecular weight of at least 5,000 daltons, at least one hydrophobicvinyl-containing monomer, and at least one cross-linking agent, whereina single polymerized silicone hydrogel contact lens body is provided ina single contact lens mold assembly, and each contact lens mold assemblycomprises a first mold section having a concave optical surface forforming an anterior surface of the silicone hydrogel contact lens bodyand a second mold section having a convex optical surface for forming aposterior surface of the silicone hydrogel contact lens body, and thefirst mold section and second mold section are coupled together;separating the polymerized silicone hydrogel contact lens bodies fromthe contact lens mold assemblies to produce delensed contact lensbodies; washing the delensed contact lens bodies with an aqueous liquidfree of volatile organic solvent to produce washed contact lenses; andsterilizing the washed contact lenses in sealed contact lens packages;wherein the batch so manufactured comprises at least twenty siliconehydrogel contact lenses, and the anterior surfaces of the sterilizedcontact lenses have clinically acceptable surface wettabilities suchthat less than five percent of the silicone hydrogel contact lenses havevisually identifiable non-wetting spots when located on eyes ofsubjects, and wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the contact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×. In oneexample, the at least one hydrophilic vinyl-containing monomer cancomprise a hydrophilic amide monomer having one N-vinyl group, or the atleast one cross-linking agent can comprise a vinyl-containingcross-linking agent, or both. In another example, the polymerizablecomposition can be free of a diluent, or free of a hydrophilic polymer,or free of N,N-dimethylacrylamide (DMA), or any combination thereof. Inyet another example, the silicone hydrogel contact lens can be free of aplasma surface treatment or of a polymeric internal wetting agentprovided by including a hydrophilic polymer in a polymerizablecomposition used to form the silicone hydrogel contact lens, or both.

One example of a batch of silicone hydrogel contact lenses in accordancewith the present disclosure is a batch comprising: at least twentypolymerized silicone hydrogel contact lenses, the polymerized siliconehydrogel contact lenses being the reaction product of a polymerizablecomposition comprising a first siloxane monomer represented by formula(1):

wherein m of formula (1) represents one integer from 3 to 10, n offormula (1) represents one integer from 1 to 10, R¹ of formula (1) is analkyl group having from 1 to 4 carbon atoms, and each R² of formula (1)is independently either a hydrogen atom or a methyl group, at least onehydrophilic vinyl-containing monomer, a second siloxane monomer havingmore than one polymerizable functional group and having a number averagemolecular weight of at least 5,000 daltons, at least one hydrophobicvinyl-containing monomer, and at least one cross-linking agent, eachsilicone hydrogel contact lens of the batch being an aqueous extractedsilicone hydrogel contact lens comprising an anterior surface and anopposing posterior surface, the posterior surface dimensioned (sized andshaped) for placement against a subject's eye; the anterior surface ofeach of the aqueous extracted contact lenses having a clinicallyacceptable surface wettability, such that less than five percent of thebatch of silicone hydrogel contact lenses has visually identifiablenon-wetting spots when located on eyes of subject; wherein thenon-wetting spots are discontinuities of the contact lens wearer'spre-lens tear film present on the anterior surface of the lens body, andare visually identifiable during a slit lamp examination at a totalmagnification from about 6× to about 70×. In one example, the at leastone hydrophilic vinyl-containing monomer can comprise a hydrophilicamide monomer having one N-vinyl group, or the at least onecross-linking agent can comprise a vinyl-containing cross-linking agent,or both. In another example, the polymerizable composition can be freeof a diluent, or free of a hydrophilic polymer, or free ofN,N-dimethylacrylamide (DMA), or any combination thereof. In yet anotherexample, the silicone hydrogel contact lens can be free of a plasmasurface treatment or of a polymeric internal wetting agent provided byincluding a hydrophilic polymer in a polymerizable composition used toform the silicone hydrogel contact lens, or both.

The first siloxane monomer and the second siloxane monomer can bepresent in the polymerizable composition at a ratio of at least 2:1based on unit parts by weight. In other words, for every unit part byweight of the second siloxane monomer present in the polymerizablecomposition, 2 or more unit parts of the first siloxane monomer are alsopresent in the polymerizable composition. In accordance with the presentdisclosure, the first siloxane monomer and the second siloxane monomercan be present in the polymerizable composition in a ratio from about2:1 to about 10:1 based on unit parts by weight of the first siloxanemonomer to the second siloxane monomer. In another example, the firstsiloxane monomer and the second siloxane monomer can be present in thepolymerizable composition in a ratio from about 3:1 to about 6:1 basedon unit parts by weight. In yet another example, the first siloxanemonomer and the second siloxane monomer can be present in thepolymerizable composition in a ratio of about 4:1 based on unit parts byweight.

As used herein, ‘unit parts’ is understood to mean unit parts by weight.For example, to prepare a formulation described as comprising x unitparts of a first siloxane monomer and y unit parts of a second siloxanemonomer, the composition can be prepared by combining x grams of thefirst siloxane with y grams of the second siloxane to obtain a total ofx+y grams of polymerizable composition, or by combining x ounces of thefirst siloxane with y ounces of the second siloxane to obtain a total ofx+y ounces of polymerizable composition, and so on. When the compositionfurther comprises additional optional ingredients such as, for example,z unit parts of a cross-linking agent, z grams of the cross-linkingagent are combined with x grams of the first siloxane monomer and ygrams of the second siloxane to obtain a total of x+y+z grams ofpolymerizable composition, and so on. Typically, a formula for apolymerizable composition will be composed of ingredients in amountstotaling from about 90 to about 110 unit parts by weight. When amountsof components of the polymerizable composition are recited herein asbeing in unit parts, it is to be understood that the unit parts of thesecomponent are based on a formula providing a total weight of thecomposition ranging from about 90 to 110 unit parts. In one example, theunit parts by weight can be based on a formula providing a total weightof the composition ranging from about 95 to 105 unit parts by weight, orfrom about 98 to 102 unit parts by weight.

As discussed herein, the present contact lenses comprise, or consist of,hydrated lens bodies comprising a polymeric component and a liquidcomponent. The polymeric component can comprise units of two or moresiloxanes, and one or more non-silicon reactive ingredients. It cantherefore be understood that the polymeric component can be the reactionproduct of a polymerizable composition comprising two or more siloxanes(the siloxane monomer component of the composition), and one or morenon-silicon reactive ingredients. As used herein, a non-silicon reactiveingredient is understood to be an ingredient which has a polymerizabledouble bond as part of its molecular structure, but which does not havea silicon atom in its molecular structure. The ingredients of thepolymerizable composition can be monomers, macromers, pre-polymers,polymers, or any combination thereof. Optionally, the ingredients of thepolymerizable composition can further include at least one hydrophilicmonomer, or at least one hydrophobic monomer, or at least onecross-linking agent. The at least one hydrophilic monomer, at least onehydrophobic monomer and at least one cross-linking agent are understoodto be silicon-free reactive ingredients. As used herein, the at leastone hydrophilic monomer can be understood to comprise a singlehydrophilic monomer, or to comprise a hydrophilic monomer componentcomposed of two or more hydrophilic monomers. Similarly, the at leastone hydrophobic monomer can be understood to comprise a singlehydrophobic monomer, or to comprise a hydrophobic monomer componentcomposed of two or more hydrophobic monomers. The at least onecross-linking agent can be understood to comprise a single cross-linkingagent, or to comprise a cross-linking agent component composed of two ormore cross-linking agents. Additionally, the polymerizable compositioncan optionally include at least one initiator, or at least one organicdiluent, or at least one surfactant, or at least one oxygen scavenger,or at least one tinting agent, or at least one UV absorber, or at leastone chain transfer agent, or any combination thereof. The optional atleast one initiator, at least one organic diluent, at least onesurfactant, at least one oxygen scavenger, at least one tinting agent,at least one UV absorber, or at least one chain transfer agent areunderstood to be non-silicon ingredients, and can be eithernon-polymerizable ingredients or polymerizable ingredients (i.e.,ingredients having a polymerizable functional group as part of theirmolecular structure).

The combination of the polymeric component and the liquid component arepresent as a hydrated lens body, which is suitable for placement on aneye of a person. The hydrated lens body has a generally convex anteriorsurface and a generally concave posterior surface, and has anequilibrium water content (EWC) greater than 10% weight by weight(wt/wt). Thus, the present contact lenses can be understood to be softcontact lenses, which as used herein, refers to contact lenses that,when fully hydrated, can be folded upon themselves without breaking.

The present contact lenses can be either daily disposable contact lensesor non-daily disposable contact lenses.

In one example, the polymerizable composition of the present disclosurecomprises a first siloxane monomer represented by formula (1):

wherein m of formula (1) represents one integer from 3 to 10, n offormula (1) represents one integer from 1 to 10, R¹ of formula (1) is analkyl group having from 1 to 4 carbon atoms, and each R² of formula (1)is independently either a hydrogen atom or a methyl group. In otherwords, on a single molecule of the siloxane monomer represented byformula 1, the first R² of formula (1), (the R² which is closest to theR¹ end group on the left side of the molecule), can be either a hydrogenatom or a methyl group, and the second R² of formula (1) (the R² whichis part of the methacrylate end group on the right side of themolecule), can also be either a hydrogen atom or a methyl group,regardless of whether the first R² of formula (1) is a hydrogen atom ora methyl group. The polymerizable composition also comprises a secondsiloxane monomer. The first siloxane monomer and the second siloxanemonomer are present in the polymerizable composition at a ratio of atleast 2:1 based on unit parts by weight. The second siloxane monomer hasmore than one polymerizable functional group (i.e., is a multifunctionalsiloxane monomer) and has a number average molecular weight of at least3,000 daltons. If the second siloxane monomer has two polymerizablefunctional groups, such as two methacrylate groups, it is a bifunctionalmonomer. If the second siloxane monomer has three polymerizablefunctional groups, it is a trifunctional monomer. The polymerizablecomposition also comprises at least one hydrophilic monomer, or at leastone hydrophobic monomer, or at least one cross-linking agent, or anycombination thereof.

The present disclosure also relates to a new silicone hydrogel contactlens or to new silicone hydrogel contact lenses. A silicone hydrogelcontact lens in accordance with the present disclosure comprises apolymeric lens body. The polymeric lens body is the reaction product ofa polymerizable composition or contact lens formulation. Thepolymerizable composition used to produce the present silicone hydrogelcontact lens or lenses comprises a first siloxane monomer represented byformula (1):

wherein m of formula (1) represents one integer from 3 to 10, n offormula (1) represents one integer from 1 to 10, R¹ of formula (1) is analkyl group having from 1 to 4 carbon atoms, and each R² of formula (1)is independently either a hydrogen atom or a methyl group. Thepolymerizable composition also comprises a second siloxane monomerhaving more than one polymerizable functional group and having a numberaverage molecular weight of at least 3,000 daltons. The first siloxanemonomer and the second siloxane monomer are present in the polymerizablecomposition at a ratio of at least 2:1 based on unit parts by weight.The polymerizable composition also comprises at least one hydrophilicmonomer, or at least one hydrophobic monomer, or at least onecross-linking agent, or any combination thereof.

As used herein, a molecular weight is understood to refer to the numberaverage molecular weight. The number average molecular weight is theordinary arithmetic mean or average of the molecular weights of theindividual molecules present in the sample of a monomer. As theindividual molecules in a sample of monomer may vary slightly from oneanother in molar mass, some level of polydispersity may be present inthe sample. As used herein, when the second siloxane monomer, or anyother monomer, macromer, pre-polymer, or polymer, of the polymerizablecomposition is polydisperse, the term “molecular weight” refers to thenumber average molecular weight of the monomer or ingredient. As oneexample, a sample of the second siloxane monomer can have a numberaverage molecular weight of about 15,000 daltons, but if the sample ispolydisperse, the actual molecular weights of the individual monomerspresent in the sample may range from 12,000 daltons to 18,000 daltons.

The number average molecular weight can be the absolute number averagemolecular weight as determined by proton nuclear magnetic resonance(NMR) end group analysis, as understood by persons of ordinary skill inthe art. Molecular weights may also be determined using gel permeationchromatography, as understood by persons of ordinary skill in the art,or may be provided by suppliers of the chemicals.

The molecular weight of the first siloxane monomer is less than 2,000daltons. In one example, the molecular weight of the first siloxanemonomer can be less than 1,000 daltons. In another example, themolecular weight of the first siloxane monomer can be from 400 to 700daltons. Additional details of the first siloxane monomer can beunderstood from US20090299022, the entire content of which is herebyincorporated by reference. As can be appreciated from formula (1), thefirst siloxane monomer has a single methacrylic polymerizable end group.

In one example of the present contact lenses, the second siloxanemonomer can have a number average molecular weight of at least 4,000daltons, or at least 7,000 daltons, or at least 9,000 daltons, or atleast 11,000 daltons. The number average molecular weight of the secondsiloxane monomer can be less than 20,000 daltons. Thus, in somecontexts, the second siloxane monomer can be considered a macromer, butit will be referred to as a monomer herein since it forms a unit part ofa polymer formed with the other reactive components of the polymerizablecomposition.

The polymerizable composition also comprises at least one hydrophilicmonomer, or at least one hydrophobic monomer, or at least onecross-linking agent, or any combination thereof. As used herein, thepreceding three types of chemicals are non-silicon chemicals (i.e.,chemicals whose molecular structure does not include a silicon atom) andthus are different from the siloxane monomers present in thepolymerizable compositions. The polymerizable compositions can beunderstood to comprise at least two siloxane monomers, and othernon-silicon hydrophilic monomers, or non-silicon hydrophobic monomers,or non-silicon cross-linking agents, or any combination thereof,although, optionally, the polymerizable composition can further compriseat least a third siloxane monomer.

The first siloxane monomer, the second siloxane monomer and the optionalat least one third siloxane monomer comprise the siloxane monomercomponent of the polymerizable composition. Each of the first siloxanemonomer, or the second siloxane monomer, or the optional third siloxanemonomer, or any combination thereof, can be a hydrophilic siloxanemonomer, or a hydrophobic siloxane monomer, or can have both hydrophilicregions and hydrophobic regions, depending on the amount and location ofany hydrophilic components, such as units of ethylene glycol,polyethylene glycol and the like, present in the molecular structure ofthe siloxane monomers. For example, the second siloxane monomer, or theoptional at least one third siloxane monomer, or any combinationthereof, can contain hydrophilic components within the main chain of thesiloxane molecule, can contain hydrophilic components within one or moreside chains of the siloxane molecule, or any combination thereof. Forexample, the siloxane monomer can have at least one unit of ethyleneglycol adjacent to a polymerizable functional group in the main chain ofthe siloxane molecule. The at least one unit of ethylene glycol adjacentto a polymerizable functional group in the main chain of the siloxanemolecule can be separated from the polymerizable functional group by acarbon chain 1-10 units in length (i.e., where the ethylene glycol unitis bonded to the first carbon in the chain, and the polymerizablefunctional group is bonded to the last carbon in the chain). Thesiloxane monomer can have at least one unit of ethylene glycol adjacentto polymerizable functional groups present on both ends of the mainchain of the siloxane molecule. The siloxane monomer can have at leastone unit of ethylene glycol present in at least one side chain of thesiloxane molecule. The at least one unit of ethylene glycol present inat least one side chain of the siloxane molecule can be part of a sidechain bonded to a silicon atom of the main chain of the siloxanemolecule. The siloxane molecule can have both at least one unit ofethylene glycol adjacent to polymerizable functional groups present onboth ends of the main chain of the siloxane molecule, and at least oneunit of ethylene glycol present in at least one side chain of thesiloxane molecule.

The hydrophilicity or hydrophobicity of a monomer can be determinedusing conventional techniques, such as, for example, based on themonomer's aqueous solubility. For purposes of the present disclosure, ahydrophilic monomer is a monomer that is visibly soluble in an aqueoussolution at room temperature (e.g. about 20-25 degrees C.). For example,a hydrophilic monomer can be understood to be any monomer for which 50grams of the monomer are visibly fully soluble in 1 liter of water at20° C. (i.e., ≧5% soluble in water) as determined using a standard shakeflask method as known to persons of ordinary skill in the art. Ahydrophobic monomer, as used herein, is a monomer that is visiblyinsoluble in an aqueous solution at room temperature, such thatseparate, visually identifiable phases are present in the aqueoussolution, or such that the aqueous solution appears cloudy and separatesinto two distinct phases over time after sitting at room temperature.For example, a hydrophobic monomer can be understood to be any monomerfor which 50 grams of the monomer are not visibly fully soluble in 1liter of water at 20° C.

In one example of the present contact lenses, the first siloxane monomercan be represented by formula (1) where m of formula (1) is 4, n offormula (1) is 1, R¹ of formula (1) is a butyl group, and each R² offormula (1) is independently either a hydrogen atom or a methyl group.One example of such a first siloxane monomer is identified herein as Si1in the Examples.

In another example of the present contact lenses, the second siloxanemonomer can be a dual-end methacrylate end-capped polydimethylsiloxanehaving a number average molecular weight of at least 4,000 daltons. Itwill be understood that such siloxane monomers are bifunctional.

As an example of a bifunctional siloxane monomer useful in the presentsilicone hydrogel contact lenses, the second siloxane monomer can berepresented by formula (2):

wherein R₁ of formula (2) is selected from either hydrogen atom or amethyl group; R₂ of formula (2) is selected from either of hydrogen atomor a hydrocarbon group having 1 to 4 carbon atoms; m of formula (2)represents an integer of from 0 to 10; n of formula (2) represents aninteger of from 4 to 100; a and b represent integers of 1 or more; a+bis equal to 20-500; b/(a+b) is equal to 0.01-0.22; and the configurationof siloxane units includes a random configuration. In one example inwhich the second siloxane monomer is a monomer represented by formula(2), m of formula (2) is 0, n of formula (2) is an integer from 5 to 15,a is an integer from 65 to 90, b is an integer from 1 to 10, R₁ offormula (2) is a methyl group, and R₂ of formula (2) is either ahydrogen atom or a hydrocarbon group having 1 to 4 carbon atoms. Oneexample of such a second siloxane monomer as represented by formula (2)is abbreviated Si2 in the Examples. The number average molecular weightfor this second siloxane monomer represented by formula (2) can be fromabout 9,000 daltons to about 10,000 daltons. In another example, thesecond siloxane monomer represented by formula (2) can have a molecularweight from about 5,000 daltons to about 10,000 daltons. It can beappreciated that the second siloxane represented by formula (2) is abifunctional siloxane having two terminal methacrylic groups. Additionaldetails of this second siloxane monomer can be found in US20090234089,the entire content of which is incorporated herein by reference.

One example of a method of manufacturing a batch of silicone hydrogelcontact lenses of the present disclosure is a method comprising:providing polymerized silicone hydrogel contact lens bodies in contactlens mold assemblies, the polymerized silicone hydrogel contact lensbodies being the reaction product of a polymerizable compositioncomprising a first siloxane monomer, a second siloxane monomerrepresented by formula (2):

wherein R₁ of formula (2) is selected from either hydrogen atom or amethyl group; R₂ of formula (2) is selected from either of hydrogen atomor a hydrocarbon group having 1 to 4 carbon atoms; m of formula (2)represents an integer of from 0 to 10; n of formula (2) represents aninteger of from 4 to 100; a and b represent integers of 1 or more; a+bis equal to 20-500; b/(a+b) is equal to 0.01-0.22; and the configurationof siloxane units includes a random configuration, at least onehydrophobic vinyl-containing monomer, and at least one cross-linkingagent, wherein a single polymerized silicone hydrogel contact lens bodyis provided in a single contact lens mold assembly, and each contactlens mold assembly comprises a first mold section having a concaveoptical surface for forming an anterior surface of the silicone hydrogelcontact lens body and a second mold section having a convex opticalsurface for forming a posterior surface of the silicone hydrogel contactlens body, and the first mold section and second mold section arecoupled together; separating the polymerized silicone hydrogel contactlens bodies from the contact lens mold assemblies to produce delensedcontact lens bodies; washing the delensed contact lens bodies with anaqueous liquid free of volatile organic solvent to produce washedcontact lenses; and sterilizing the washed contact lenses in sealedcontact lens packages; wherein the batch so manufactured comprises atleast twenty silicone hydrogel contact lenses, and the anterior surfacesof the sterilized contact lenses have clinically acceptable surfacewettabilities such that less than five percent of the silicone hydrogelcontact lenses have visually identifiable non-wetting spots when locatedon eyes of subjects, and wherein the non-wetting spots arediscontinuities of the contact lens wearer's pre-lens tear film presenton the anterior surface of the contact lens, and are visuallyidentifiable during a slit lamp examination at a total magnificationfrom about 6× to about 70×. In one example, the at least one hydrophilicvinyl-containing monomer can comprise a hydrophilic amide monomer havingone N-vinyl group, or the at least one cross-linking agent can comprisea vinyl-containing cross-linking agent, or both. In another example, thepolymerizable composition can be free of a diluent, or free of ahydrophilic polymer, or free of N,N-dimethylacrylamide (DMA), or anycombination thereof. In yet another example, the silicone hydrogelcontact lens can be free of a plasma surface treatment or of a polymericinternal wetting agent provided by including a hydrophilic polymer in apolymerizable composition used to form the silicone hydrogel contactlens, or both.

Another example of a method of manufacturing a batch of siliconehydrogel contact lenses of the present disclosure is a methodcomprising: providing polymerized silicone hydrogel contact lens bodiesin contact lens mold assemblies, the polymerized silicone hydrogelcontact lens bodies being the reaction product of a polymerizablecomposition comprising a first siloxane monomer having a number averagemolecular weight of from 400 daltons to 700 daltons, a second siloxanemonomer represented by formula (2):

wherein R₁ of formula (2) is selected from either hydrogen atom or amethyl group; R₂ of formula (2) is selected from either of hydrogen atomor a hydrocarbon group having 1 to 4 carbon atoms; m of formula (2)represents an integer of from 0 to 10; n of formula (2) represents aninteger of from 4 to 100; a and b represent integers of 1 or more; a+bis equal to 20-500; b/(a+b) is equal to 0.01-0.22; and the configurationof siloxane units includes a random configuration, at least onehydrophobic vinyl-containing monomer, and at least one cross-linkingagent, wherein a single polymerized silicone hydrogel contact lens bodyis provided in a single contact lens mold assembly, and each contactlens mold assembly comprises a first mold section having a concaveoptical surface for forming an anterior surface of the silicone hydrogelcontact lens body and a second mold section having a convex opticalsurface for forming a posterior surface of the silicone hydrogel contactlens body, and the first mold section and second mold section arecoupled together; separating the polymerized silicone hydrogel contactlens bodies from the contact lens mold assemblies to produce delensedcontact lens bodies; washing the delensed contact lens bodies with anaqueous liquid free of volatile organic solvent to produce washedcontact lenses; and sterilizing the washed contact lenses in sealedcontact lens packages; wherein the batch so manufactured comprises atleast twenty silicone hydrogel contact lenses, and the anterior surfacesof the sterilized contact lenses have clinically acceptable surfacewettabilities such that less than five percent of the silicone hydrogelcontact lenses have visually identifiable non-wetting spots when locatedon eyes of subjects, and wherein the non-wetting spots arediscontinuities of the contact lens wearer's pre-lens tear film presenton the anterior surface of the contact lens, and are visuallyidentifiable during a slit lamp examination at a total magnificationfrom about 6× to about 70×. In one example, the at least one hydrophilicvinyl-containing monomer can comprise a hydrophilic amide monomer havingone N-vinyl group, or the at least one cross-linking agent can comprisea vinyl-containing cross-linking agent, or both. In another example, thepolymerizable composition can be free of a diluent, or free of ahydrophilic polymer, or free of N,N-dimethylacrylamide (DMA), or anycombination thereof. In yet another example, the silicone hydrogelcontact lens can be free of a plasma surface treatment or of a polymericinternal wetting agent provided by including a hydrophilic polymer in apolymerizable composition used to form the silicone hydrogel contactlens, or both.

Yet another example of a method of manufacturing a batch of siliconehydrogel contact lenses of the present disclosure is a methodcomprising: providing polymerized silicone hydrogel contact lens bodiesin contact lens mold assemblies, the polymerized silicone hydrogelcontact lens bodies being the reaction product of a polymerizablecomposition comprising a first siloxane monomer represented by formula(1):

wherein m of formula (1) represents one integer from 3 to 10, n offormula (1) represents one integer from 1 to 10, R¹ of formula (1) is analkyl group having from 1 to 4 carbon atoms, and each R² of formula (1)is independently either a hydrogen atom or a methyl group, a secondsiloxane monomer represented by formula (2):

wherein R₁ of formula (2) is selected from either hydrogen atom or amethyl group; R₂ of formula (2) is selected from either of hydrogen atomor a hydrocarbon group having 1 to 4 carbon atoms; m of formula (2)represents an integer of from 0 to 10; n of formula (2) represents aninteger of from 4 to 100; a and b represent integers of 1 or more; a+bis equal to 20-500; b/(a+b) is equal to 0.01-0.22; and the configurationof siloxane units includes a random configuration, at least onehydrophobic vinyl-containing monomer, and at least one cross-linkingagent, wherein a single polymerized silicone hydrogel contact lens bodyis provided in a single contact lens mold assembly, and each contactlens mold assembly comprises a first mold section having a concaveoptical surface for forming an anterior surface of the silicone hydrogelcontact lens body and a second mold section having a convex opticalsurface for forming a posterior surface of the silicone hydrogel contactlens body, and the first mold section and second mold section arecoupled together; separating the polymerized silicone hydrogel contactlens bodies from the contact lens mold assemblies to produce delensedcontact lens bodies; washing the delensed contact lens bodies with anaqueous liquid free of volatile organic solvent to produce washedcontact lenses; and sterilizing the washed contact lenses in sealedcontact lens packages; wherein the batch so manufactured comprises atleast twenty silicone hydrogel contact lenses, and the anterior surfacesof the sterilized contact lenses have clinically acceptable surfacewettabilities such that less than five percent of the silicone hydrogelcontact lenses have visually identifiable non-wetting spots when locatedon eyes of subjects, and wherein the non-wetting spots arediscontinuities of the contact lens wearer's pre-lens tear film presenton the anterior surface of the contact lens, and are visuallyidentifiable during a slit lamp examination at a total magnificationfrom about 6× to about 70×. In one example, the at least one hydrophilicvinyl-containing monomer can comprise a hydrophilic amide monomer havingone N-vinyl group, or the at least one cross-linking agent can comprisea vinyl-containing cross-linking agent, or both. In another example, thepolymerizable composition can be free of a diluent, or free of ahydrophilic polymer, or free of N,N-dimethylacrylamide (DMA), or anycombination thereof. In yet another example, the silicone hydrogelcontact lens can be free of a plasma surface treatment or of a polymericinternal wetting agent provided by including a hydrophilic polymer in apolymerizable composition used to form the silicone hydrogel contactlens, or both.

One example of a batch of silicone hydrogel contact lenses in accordancewith the present disclosure is a batch comprising: at least twentypolymerized silicone hydrogel contact lenses, the polymerized siliconehydrogel contact lenses being the reaction product of a polymerizablecomposition comprising a first siloxane monomer, second siloxane monomerrepresented by formula (2):

wherein R₁ of formula (2) is selected from either hydrogen atom or amethyl group; R₂ of formula (2) is selected from either of hydrogen atomor a hydrocarbon group having 1 to 4 carbon atoms; m of formula (2)represents an integer of from 0 to 10; n of formula (2) represents aninteger of from 4 to 100; a and b represent integers of 1 or more; a+bis equal to 20-500; b/(a+b) is equal to 0.01-0.22; and the configurationof siloxane units includes a random configuration, at least onehydrophobic vinyl-containing monomer, and at least one cross-linkingagent, each silicone hydrogel contact lens of the batch being an aqueousextracted silicone hydrogel contact lens comprising an anterior surfaceand an opposing posterior surface, the posterior surface dimensioned(sized and shaped) for placement against a subject's eye; the anteriorsurface of each of the aqueous extracted contact lenses having aclinically acceptable surface wettability, such that less than fivepercent of the batch of silicone hydrogel contact lenses has visuallyidentifiable non-wetting spots when located on eyes of subject; whereinthe non-wetting spots are discontinuities of the contact lens wearer'spre-lens tear film present on the anterior surface of the lens body, andare visually identifiable during a slit lamp examination at a totalmagnification from about 6× to about 70×. In one example, the at leastone hydrophilic vinyl-containing monomer can comprise a hydrophilicamide monomer having one N-vinyl group, or the at least onecross-linking agent can comprise a vinyl-containing cross-linking agent,or both. In another example, the polymerizable composition can be freeof a diluent, or free of a hydrophilic polymer, or free ofN,N-dimethylacrylamide (DMA), or any combination thereof. In yet anotherexample, the silicone hydrogel contact lens can be free of a plasmasurface treatment or of a polymeric internal wetting agent provided byincluding a hydrophilic polymer in a polymerizable composition used toform the silicone hydrogel contact lens, or both.

Another example of a batch of silicone hydrogel contact lenses inaccordance with the present disclosure is a batch comprising: at leasttwenty polymerized silicone hydrogel contact lenses, the polymerizedsilicone hydrogel contact lenses being the reaction product of apolymerizable composition comprising a first siloxane monomer having anumber average molecular weight of from 400 daltons to 700 daltons, asecond siloxane monomer represented by formula (2):

wherein R₁ of formula (2) is selected from either hydrogen atom or amethyl group; R₂ of formula (2) is selected from either of hydrogen atomor a hydrocarbon group having 1 to 4 carbon atoms; m of formula (2)represents an integer of from 0 to 10; n of formula (2) represents aninteger of from 4 to 100; a and b represent integers of 1 or more; a+bis equal to 20-500; b/(a+b) is equal to 0.01-0.22; and the configurationof siloxane units includes a random configuration, at least onehydrophobic vinyl-containing monomer, and at least one cross-linkingagent, each silicone hydrogel contact lens of the batch being an aqueousextracted silicone hydrogel contact lens comprising an anterior surfaceand an opposing posterior surface, the posterior surface dimensioned(sized and shaped) for placement against a subject's eye; the anteriorsurface of each of the aqueous extracted contact lenses having aclinically acceptable surface wettability, such that less than fivepercent of the batch of silicone hydrogel contact lenses has visuallyidentifiable non-wetting spots when located on eyes of subject; whereinthe non-wetting spots are discontinuities of the contact lens wearer'spre-lens tear film present on the anterior surface of the lens body, andare visually identifiable during a slit lamp examination at a totalmagnification from about 6× to about 70×. In one example, the at leastone hydrophilic vinyl-containing monomer can comprise a hydrophilicamide monomer having one N-vinyl group, or the at least onecross-linking agent can comprise a vinyl-containing cross-linking agent,or both. In another example, the polymerizable composition can be freeof a diluent, or free of a hydrophilic polymer, or free ofN,N-dimethylacrylamide (DMA), or any combination thereof. In yet anotherexample, the silicone hydrogel contact lens can be free of a plasmasurface treatment or of a polymeric internal wetting agent provided byincluding a hydrophilic polymer in a polymerizable composition used toform the silicone hydrogel contact lens, or both.

Yet another example of a batch of silicone hydrogel contact lenses inaccordance with the present disclosure is a batch comprising: at leasttwenty polymerized silicone hydrogel contact lenses, the polymerizedsilicone hydrogel contact lenses being the reaction product of apolymerizable composition comprising a first siloxane monomerrepresented by formula (1):

wherein m of formula (1) represents one integer from 3 to 10, n offormula (1) represents one integer from 1 to 10, R¹ of formula (1) is analkyl group having from 1 to 4 carbon atoms, and each R² of formula (1)is independently either a hydrogen atom or a methyl group, a secondsiloxane monomer represented by formula (2):

wherein R₁ of formula (2) is selected from either hydrogen atom or amethyl group; R₂ of formula (2) is selected from either of hydrogen atomor a hydrocarbon group having 1 to 4 carbon atoms; m of formula (2)represents an integer of from 0 to 10; n of formula (2) represents aninteger of from 4 to 100; a and b represent integers of 1 or more; a+bis equal to 20-500; b/(a+b) is equal to 0.01-0.22; and the configurationof siloxane units includes a random configuration, at least onehydrophobic vinyl-containing monomer, and at least one cross-linkingagent, each silicone hydrogel contact lens of the batch being an aqueousextracted silicone hydrogel contact lens comprising an anterior surfaceand an opposing posterior surface, the posterior surface dimensioned(sized and shaped) for placement against a subject's eye; the anteriorsurface of each of the aqueous extracted contact lenses having aclinically acceptable surface wettability, such that less than fivepercent of the batch of silicone hydrogel contact lenses has visuallyidentifiable non-wetting spots when located on eyes of subject; whereinthe non-wetting spots are discontinuities of the contact lens wearer'spre-lens tear film present on the anterior surface of the lens body, andare visually identifiable during a slit lamp examination at a totalmagnification from about 6× to about 70×. In one example, the at leastone hydrophilic vinyl-containing monomer can comprise a hydrophilicamide monomer having one N-vinyl group, or the at least onecross-linking agent can comprise a vinyl-containing cross-linking agent,or both. In another example, the polymerizable composition can be freeof a diluent, or free of a hydrophilic polymer, or free ofN,N-dimethylacrylamide (DMA), or any combination thereof. In yet anotherexample, the silicone hydrogel contact lens can be free of a plasmasurface treatment or of a polymeric internal wetting agent provided byincluding a hydrophilic polymer in a polymerizable composition used toform the silicone hydrogel contact lens, or both.

As another example of a bifunctional siloxane monomer useful in thepresent silicone hydrogel contact lenses, the second siloxane monomercan be represented by formula (3):

wherein R³ is selected from either hydrogen atom or a methyl group, m offormula (3) represents an integer from 0 to 10, and n of formula (3)represents an integer from 1 to 500. In one example, the second siloxanemonomer is represented by formula 3, and R³ is a methyl group, m offormula (3) is 0, and n of formula (3) is one integer from 40 to 60. Thesecond siloxane monomer of this example is represented by formula (4),and is abbreviated Si3 in the Examples (available from Gelest, Inc.(Morrisville, Pa., USA) as product code DMS-R18):

The siloxane of formula (4) can have a number average molecular weightfrom about 4,000 to about 4,500 daltons.

Another example of a second siloxane monomer that can be included in thepresent polymerizable compositions is represented by formula (5) below:

wherein n is an integer from 100 to 140, m and p are both integers from6-9, h is an integer from 3-6, and the Mn=12,800, and the Mw=16,200. Thesiloxane monomer of formula (5) has a chemical name ofα-ω-Bis(methacryloyloxyethyl iminocarboxyethyloxypropyl)-poly(dimethylsiloxane)-poly(trifluoropropylmethylsiloxane)-poly(ω-methoxy-poly(ethyleneglycol)propylmethylsiloxane).

In some polymerizable compositions that include the siloxane monomer offormula (5), a monofunctional siloxane monomer can be provided in thecomposition as represented by formula (6):

wherein n is an integer from 13-16, and the molecular weight is about1500 daltons. The monofunctional siloxane monomer of formula (6) has achemical name of α-Methacryloyloxyethyliminocarboxyethyloxypropyl-poly(dimethylsiloxy)-butyldimethylsilane.Silicone hydrogel contact lenses comprising units of the siloxanemonomer of formula (5) and formula (6) can be cast molded in PBT contactlens mold assemblies and washed without volatile organic solvents andhave clinically acceptable surface wettabilities, as described herein.

One example of a method of manufacturing a batch of silicone hydrogelcontact lenses of the present disclosure is a method comprising:providing polymerized silicone hydrogel contact lens bodies in contactlens mold assemblies, the polymerized silicone hydrogel contact lensbodies being the reaction product of a polymerizable compositioncomprising a siloxane monomer represented by formula (6):

wherein n is an integer from 13-16, and the molecular weight is about1500 daltons, at least one hydrophobic vinyl-containing monomer, and atleast one cross-linking agent, wherein a single polymerized siliconehydrogel contact lens body is provided in a single contact lens moldassembly, and each contact lens mold assembly comprises a first moldsection having a concave optical surface for forming an anterior surfaceof the silicone hydrogel contact lens body and a second mold sectionhaving a convex optical surface for forming a posterior surface of thesilicone hydrogel contact lens body, and the first mold section andsecond mold section are coupled together; separating the polymerizedsilicone hydrogel contact lens bodies from the contact lens moldassemblies to produce delensed contact lens bodies; washing the delensedcontact lens bodies with an aqueous liquid free of volatile organicsolvent to produce washed contact lenses; and sterilizing the washedcontact lenses in sealed contact lens packages; wherein the batch somanufactured comprises at least twenty silicone hydrogel contact lenses,and the anterior surfaces of the sterilized contact lenses haveclinically acceptable surface wettabilities such that less than fivepercent of the silicone hydrogel contact lenses have visuallyidentifiable non-wetting spots when located on eyes of subjects, andwherein the non-wetting spots are discontinuities of the contact lenswearer's pre-lens tear film present on the anterior surface of thecontact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×. In oneexample, the at least one hydrophilic vinyl-containing monomer cancomprise a hydrophilic amide monomer having one N-vinyl group, or the atleast one cross-linking agent can comprise a vinyl-containingcross-linking agent, or both. In another example, the polymerizablecomposition can be free of a diluent, or free of a hydrophilic polymer,or free of N,N-dimethylacrylamide (DMA), or any combination thereof. Inyet another example, the silicone hydrogel contact lens can be free of aplasma surface treatment or of a polymeric internal wetting agentprovided by including a hydrophilic polymer in a polymerizablecomposition used to form the silicone hydrogel contact lens, or both.

Another example of a method of manufacturing a batch of siliconehydrogel contact lenses of the present disclosure is a methodcomprising: providing polymerized silicone hydrogel contact lens bodiesin contact lens mold assemblies, the polymerized silicone hydrogelcontact lens bodies being the reaction product of a polymerizablecomposition comprising a siloxane monomer represented by formula (6):

wherein n is an integer from 13-16, and the molecular weight is about1500 daltons, at least one hydrophobic vinyl-containing monomer, and atleast one cross-linking agent, wherein a single polymerized siliconehydrogel contact lens body is provided in a single contact lens moldassembly, and each contact lens mold assembly comprises a first moldsection having a concave optical surface for forming an anterior surfaceof the silicone hydrogel contact lens body and a second mold sectionhaving a convex optical surface for forming a posterior surface of thesilicone hydrogel contact lens body, at least one of the first moldsection and the second mold section comprising a polar material resin,and the first mold section and second mold section are coupled together;separating the polymerized silicone hydrogel contact lens bodies fromthe contact lens mold assemblies to produce delensed contact lensbodies; washing the delensed contact lens bodies with an aqueous liquidfree of volatile organic solvent to produce washed contact lenses; andsterilizing the washed contact lenses in sealed contact lens packages;wherein the batch so manufactured comprises at least twenty siliconehydrogel contact lenses, and the anterior surfaces of the sterilizedcontact lenses have clinically acceptable surface wettabilities suchthat less than five percent of the silicone hydrogel contact lenses havevisually identifiable non-wetting spots when located on eyes ofsubjects, and wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the contact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×. In oneexample, the at least one hydrophilic vinyl-containing monomer cancomprise a hydrophilic amide monomer having one N-vinyl group, or the atleast one cross-linking agent can comprise a vinyl-containingcross-linking agent, or both. In another example, the polymerizablecomposition can be free of a diluent, or free of a hydrophilic polymer,or free of N,N-dimethylacrylamide (DMA), or any combination thereof. Inyet another example, the silicone hydrogel contact lens can be free of aplasma surface treatment or of a polymeric internal wetting agentprovided by including a hydrophilic polymer in a polymerizablecomposition used to form the silicone hydrogel contact lens, or both.

One example of a batch of silicone hydrogel contact lenses in accordancewith the present disclosure is a batch comprising: at least twentypolymerized silicone hydrogel contact lenses, the polymerized siliconehydrogel contact lenses being the reaction product of a polymerizablecomposition comprising a siloxane monomer represented by formula (6):

wherein n is an integer from 13-16, and the molecular weight is about1500 daltons, at least one hydrophobic vinyl-containing monomer, and atleast one cross-linking agent, each silicone hydrogel contact lens ofthe batch being an aqueous extracted silicone hydrogel contact lenscomprising an anterior surface and an opposing posterior surface, theposterior surface dimensioned (sized and shaped) for placement against asubject's eye; the anterior surface of each of the aqueous extractedcontact lenses having a clinically acceptable surface wettability, suchthat less than five percent of the batch of silicone hydrogel contactlenses has visually identifiable non-wetting spots when located on eyesof subject; wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the lens body, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×. In oneexample, the at least one hydrophilic vinyl-containing monomer cancomprise a hydrophilic amide monomer having one N-vinyl group, or the atleast one cross-linking agent can comprise a vinyl-containingcross-linking agent, or both. In another example, the polymerizablecomposition can be free of a diluent, or free of a hydrophilic polymer,or free of N,N-dimethylacrylamide (DMA), or any combination thereof. Inyet another example, the silicone hydrogel contact lens can be free of aplasma surface treatment or of a polymeric internal wetting agentprovided by including a hydrophilic polymer in a polymerizablecomposition used to form the silicone hydrogel contact lens, or both.

Another example of a batch of silicone hydrogel contact lenses inaccordance with the present disclosure is a batch comprising: at leasttwenty polymerized silicone hydrogel contact lenses, the polymerizedsilicone hydrogel contact lenses being the reaction product of apolymerizable composition cured in a contact lens mold assembly, eachcontact lens mold assembly comprising a first mold section having aconcave optical surface for forming an anterior surface of the siliconehydrogel contact lens body and a second mold section having a convexoptical surface for forming a posterior surface of the silicone hydrogelcontact lens body, at least one of the first mold section or the secondmold section comprising a polar resin, the polymerizable compositioncomprising a siloxane monomer represented by formula (6):

wherein n is an integer from 13-16, and the molecular weight is about1500 daltons, at least one hydrophobic vinyl-containing monomer, and atleast one cross-linking agent, each silicone hydrogel contact lens ofthe batch being an aqueous extracted silicone hydrogel contact lenscomprising an anterior surface and an opposing posterior surface, theposterior surface dimensioned (sized and shaped) for placement against asubject's eye; the anterior surface of each of the aqueous extractedcontact lenses having a clinically acceptable surface wettability, suchthat less than five percent of the batch of silicone hydrogel contactlenses has visually identifiable non-wetting spots when located on eyesof subject; wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the lens body, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×. In oneexample, the at least one hydrophilic vinyl-containing monomer cancomprise a hydrophilic amide monomer having one N-vinyl group, or the atleast one cross-linking agent can comprise a vinyl-containingcross-linking agent, or both. In another example, the polymerizablecomposition can be free of a diluent, or free of a hydrophilic polymer,or free of N,N-dimethylacrylamide (DMA), or any combination thereof. Inyet another example, the silicone hydrogel contact lens can be free of aplasma surface treatment or of a polymeric internal wetting agentprovided by including a hydrophilic polymer in a polymerizablecomposition used to form the silicone hydrogel contact lens, or both.

The polymerizable compositions used to prepare the present siliconehydrogel contact lenses can also include additional ingredients otherthan those described above. For example, some polymerizable compositionscan include at least one third siloxane monomer. The polymerizablecompositions can comprise one third siloxane monomer, or can comprise athird siloxane monomer component where the third siloxane monomercomponent is comprised of two or more one siloxane monomers, each ofwhich differ from the first siloxane monomer and the second siloxanemonomer of the polymerizable composition. Examples of the third siloxanemonomer or third siloxane monomer component can include poly(organosiloxane) monomers or macromers or prepolymers, such as, forexample, 3-[tris(trimethylsiloxy)silyl]propyl allyl carbamate, or3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate, ortrimethylsilylethyl vinyl carbonate, or trimethylsilylmethyl vinylcarbonate, or 3-[tris (trimethylsilyloxy) silyl]propyl methacrylate(TRIS), or 3-methaycryloxy-2-hydroxypropyloxy) propylbis(trimethylsiloxy)methylsilane (SiGMA), or methyldi (trimethylsiloxy)silylpropylglycerolethyl methacrylate (SiGEMA), ormonomethacryloxypropyl terminated polydimethylsiloxane (MCS-M11),MCR-M07, or monomethacryloxypropyl terminated mono-n-butyl terminatedpolydimethyl siloxane (mPDMS), or any combination thereof. In oneexample of a polymerizable composition of the present disclosure, the atleast one third siloxane can comprise one or more of the first siloxanesdescribed herein or the second siloxanes described herein, wherein theat least one third siloxane differs from the first siloxane and thesecond siloxane present in the polymerizable composition based onmolecular weight, molecular formula, or both molecular weight andformula. For example, the third siloxane monomer can be a siloxanemonomer of formula (1) having a different molecular weight than thefirst siloxane monomer of the polymerizable composition. In anotherexample, the at least one third siloxane can comprise at least one ofthe siloxanes disclosed in the following patents: US2007/0066706,US2008/0048350, U.S. Pat. No. 3,808,178, U.S. Pat. No. 4,120,570, U.S.Pat. No. 4,136,250, U.S. Pat. No. 4,153,641, US470533, U.S. Pat. No.5,070,215, U.S. Pat. No. 5,998,498, U.S. Pat. No. 5,760,100, U.S. Pat.No. 6,367,929, and EP080539, the entire content of which are herebyincorporated by reference.

As previously stated, optionally, the polymerizable compositions of thepresent disclosure can comprise at least one hydrophilic monomer. Thepolymerizable compositions can comprise a single hydrophilic monomer, orcan comprise two or more hydrophilic monomers present as the hydrophilicmonomer component. Non-silicon hydrophilic monomers which can be used asthe hydrophilic monomer or the hydrophilic monomer component in thepolymerizable compositions disclosed herein include, for example,acrylamide-containing monomers, or acrylate-containing monomers, oracrylic acid-containing monomers, or methacrylate-containing monomers,or methacrylic acid-containing monomers, or any combination thereof. Inone example, the hydrophilic monomer or monomer component can compriseor consist of a methacrylate-containing hydrophilic monomer. It isunderstood that the hydrophilic monomer or hydrophilic monomer componentis a non-silicon monomer. Examples of hydrophilic monomers which can beincluded in the present polymerizable compositions can include, forexample, N,N-dimethylacrylamide (DMA), or 2-hydroxyethyl acrylate, or2-hydroxyethyl methacrylate (HEMA), or 2-hydroxypropyl methacrylate, or2-hydroxybutyl methacrylate (HOB), or 2-hydroxybutyl acrylate, or4-hydroxybutyl acrylate glycerol methacrylate, or 2-hydroxyethylmethacrylamide, or polyethyleneglycol monomethacrylate, or methacrylicacid, or acrylic acid, or any combination thereof.

In one example, the hydrophilic monomer or hydrophilic monomer componentcan comprise or consist of a vinyl-containing monomer. Examples ofhydrophilic vinyl-containing monomers which can be provided in thepolymerizable compositions include, without limitation, N-vinylformamide, or N-vinyl acetamide, or N-vinyl-N-ethyl acetamide, orN-vinyl isopropylamide, or N-vinyl-N-methyl acetamide (VMA), or N-vinylpyrrolidone (NVP), or N-vinyl caprolactam, or N-vinyl-N-ethyl formamide,or N-vinyl formamide, or N-2-hydroxyethyl vinyl carbamate, orN-carboxy-β-alanine N-vinyl ester, 1,4-butanediol vinyl ether (BVE), orethylene glycol vinyl ether (EGVE), or diethylene glycol vinyl ether(DEGVE), or any combination thereof.

In another example, the hydrophilic monomer or hydrophilic monomercomponent of the polymerizable composition can comprise or consist of ahydrophilic amide monomer. The hydrophilic amide monomer can be ahydrophilic amide monomer having one N-vinyl group, such as, forexample, N-vinyl formamide, or N-vinyl acetamide, or N-vinyl-N-ethylacetamide, or N-vinyl isopropylamide, or N-vinyl-N-methyl acetamide(VMA), or N-vinyl pyrrolidone (NVP), or N-vinyl caprolactam, or anycombination thereof. In one example, the hydrophilic monomer orhydrophilic monomer component comprises N-vinyl-N-methyl acetamide(VMA). For example, the hydrophilic monomer or monomer component cancomprise or consist of VMA. In one particular example, the hydrophilicmonomer can be VMA.

In another example, the hydrophilic vinyl-containing monomer or monomercomponent can comprise or consist of a vinyl ether-containing monomer.Examples of vinyl ether-containing monomers include, without limitation,1,4-butanediol vinyl ether (BVE), or ethylene glycol vinyl ether (EGVE),or diethylene glycol vinyl ether (DEGVE), or any combination thereof. Inone example, the hydrophilic monomer component comprises or consists ofBVE. In another example, the hydrophilic monomer component comprises orconsists of EGVE. In yet another example, the hydrophilic vinylcomponent comprises or consists of DEGVE. In one particular example, thevinyl ether-containing monomer can be a vinyl ether-containing monomerwhich is more hydrophilic than BVE, such as, for example, DEGVE. Inanother example, the hydrophilic monomer of the polymerizablecomposition can be a mixture of a first hydrophilic monomer which is avinyl-containing monomer but which is not a vinyl ether-containingmonomer, and a second hydrophilic monomer which is a vinyl ethercontaining monomer. Such mixtures include, for example, mixtures of VMAand one or more vinyl ethers such as, for example, BVE, or DEGVE, orEGVE, or any combination thereof.

When present, the hydrophilic vinyl ether-containing monomer can bepresent in the polymerizable composition in an amount from about 1 toabout 15 unit parts, or from about 3 to about 10 unit parts. Whenpresent as a mixture with a hydrophilic vinyl-containing monomer whichis not a vinyl ether, the hydrophilic vinyl-containing monomer which isnot a vinyl ether and the hydrophilic vinyl ether-containing monomer canbe present in the polymerizable composition at a ratio of at least 3:1,or from about 3:1 to about 15:1, or of about 4:1 based on the ratio ofthe unit parts of the hydrophilic vinyl-containing monomer which is nota vinyl ether to the unit parts of the hydrophilic vinylether-containing monomer.

In yet another example, the hydrophilic vinyl-containing monomercomponent can comprise or consist of a combination of a firsthydrophilic monomer or monomer component, and a second hydrophilicmonomer or hydrophilic monomer component. In one example, the firsthydrophilic monomer has a different polymerizable functional group thanthe second hydrophilic monomer. In another example, each monomer of thefirst hydrophilic monomer has a different polymerizable functional groupthan the second hydrophilic monomer. In another example, the firsthydrophilic monomer has a different polymerizable functional group thaneach monomer of the second hydrophilic monomer component. In yet anotherexample, each monomer of the first hydrophilic monomer component has adifferent polymerizable functional group than each monomer of the secondhydrophilic monomer component.

For example, when the first hydrophilic monomer or monomer componentcomprises or consists of one or more amide-containing monomers, thesecond hydrophilic monomer or monomer component can comprise or consistof one or more non-amide monomers (i.e., one or more monomers each ofwhich do not have an amide functional group as part of their molecularstructures). As another example, when the first hydrophilic monomer ormonomer component comprises or consists of one or more vinyl-containingmonomers, the second hydrophilic monomer or monomer component cancomprise one or more non-vinyl monomers (i.e., one or more monomers eachof which do not have a vinyl polymerizable functional group as part oftheir molecular structures). In another example, when the firsthydrophilic monomer or monomer component comprises or consists of one ormore amide monomers each having an N-vinyl group, the second hydrophilicmonomer or monomer component can comprise or consist of one or morenon-amide monomers. When the first hydrophilic monomer or monomercomponent comprise or consists of one or more non-acrylate monomers(i.e., one or more monomers each of which do not have an acrylate ormethacrylate polymerizable functional group as part of their molecularstructures), the second hydrophilic monomer or monomer component cancomprise or consist of one or more acrylate-containing monomers, or oneor more methacrylate-containing monomers, or any combination thereof.When the first hydrophilic monomer or monomer components comprises orconsists of one or more non-vinyl ether-containing monomers (i.e., oneor more monomers each of which do not have a vinyl ether polymerizablefunctional group as part of their molecular structures), the secondhydrophilic monomer or monomer component can comprise or consist of oneor more vinyl ether-containing monomers. In a particular example, thefirst hydrophilic monomer or monomer component can comprise or consistof one or more amide-containing monomers each having an N-vinyl group,and the second hydrophilic monomer or monomer component can comprise orconsist of one or more vinyl ether-containing monomers.

In one example, when the first hydrophilic monomer or monomer componentcomprises or consists of a hydrophilic amide-containing monomer havingone N-vinyl group, the second hydrophilic monomer or monomer componentcan comprise or consist of a vinyl ether-containing monomer. In aparticular example, the first hydrophilic monomer can comprise VMA, andthe second hydrophilic monomer or monomer component can comprise BVE orEGVE or DEGVE or any combination thereof. The first hydrophilic monomercan comprise VMA and the second hydrophilic monomer can comprise BVE.The first hydrophilic monomer can comprise VMA and the secondhydrophilic monomer can comprise EGVE. The first hydrophilic monomer cancomprise VMA and the second hydrophilic monomer can comprise DEGVE. Thefirst hydrophilic monomer can comprise VMA, and the second hydrophilicmonomer component can comprise EGVE and DEGVE.

Similarly, the first hydrophilic monomer can be VMA, and the secondhydrophilic monomer or monomer component can comprise BVE or EGVE orDEGVE or any combination thereof. The first hydrophilic monomer can beVMA and the second hydrophilic monomer can be BVE. The first hydrophilicmonomer can be VMA and the second hydrophilic monomer can be EGVE. Thefirst hydrophilic monomer can comprise VMA and the second hydrophilicmonomer can be DEGVE. The first hydrophilic monomer can be VMA, and thesecond hydrophilic monomer component can be a combination of EGVE andDEGVE.

In another example, the non-silicon hydrophilic vinyl-containing monomercan have any molecular weight, such as a molecular weight less than 400daltons, or less than 300 daltons, or less than 250 daltons, or lessthan 200 daltons, or less than 150 daltons, or from about 75 to about200 daltons.

When a hydrophilic monomer or a hydrophilic monomer component is presentin the polymerizable composition, the hydrophilic monomer or monomercomponent can be present in the polymerizable composition in an amountfrom 30 to 60 unit parts of the polymerizable composition. Thehydrophilic monomer or monomer component can be present in thepolymerizable composition from 40 to 55 unit parts, or from 45 to 50unit parts by weight. When the hydrophilic monomer component of thepolymerizable composition comprises a first hydrophilic monomer ormonomer component and a second hydrophilic monomer or monomer component,the second hydrophilic monomer or monomer component can be present inthe polymerizable composition in an amount from 0.1 to 20 unit parts ofthe polymerizable composition. For example, of the total amount of from30 to 60 unit parts of hydrophilic monomer or monomer component presentin the polymerizable composition, 29.9 to 40 unit parts can comprise thefirst hydrophilic monomer or monomer component, and 0.1 to 20 unit partscan comprise the second hydrophilic monomer or monomer component. Inanother example, the second hydrophilic monomer or monomer component canbe present in the polymerizable composition from 1 to 15 unit parts, orfrom 2 to 10 unit parts, or from 3 to 7 unit parts.

As used herein, a vinyl-containing monomer is a monomer having a singlepolymerizable carbon-carbon double bond (i.e., a vinyl polymerizablefunctional group) present in its molecular structure, where, under freeradical polymerization, the carbon-carbon double bond in the vinylpolymerizable functional group is less reactive than the carbon-carbondouble bond present in an acrylate or a methacrylate polymerizablefunctional group. In other words, although a carbon-carbon double bondis present in acrylate groups and methacrylate groups, as understoodherein, monomers comprising a single acrylate or methacrylatepolymerizable group are not considered to be vinyl-containing monomers.Examples of polymerizable groups having carbon-carbon double bonds whichare less reactive than the carbon-carbon double bonds of acrylate ormethacrylate polymerizable groups include vinyl amide, vinyl ether,vinyl ester, and allyl ester polymerizable groups. Thus, as used herein,examples of vinyl-containing monomers include monomers having a singlevinyl amide, a single vinyl ether, a single vinyl ester, or a singleallyl ester polymerizable group.

In addition, the polymerizable compositions of the present disclosurecan optionally comprise at least one non-silicon hydrophobic monomer.The at least one hydrophobic monomer of the polymerizable compositioncan be one hydrophobic monomer, or can comprise a hydrophilic monomercomponent composed of at least two hydrophilic monomers. Examples ofhydrophobic monomers that can be used in the polymerizable compositionsdisclosed herein, include, without limitation, acrylate-containinghydrophobic monomers, or methacrylate-containing hydrophobic monomers,or any combination thereof. Examples of hydrophobic monomers include,without limitation, methyl acrylate, or ethyl acrylate, or propylacrylate, or isopropyl acrylate, or cyclohexyl acrylate, or 2-ethylhexylacrylate, or methyl methacrylate (MMA), or ethyl methacrylate, or propylmethacrylate, or butyl acrylate, or vinyl acetate, or vinyl propionate,or vinyl butyrate, or vinyl valerate, or styrene, or chloroprene, orvinyl chloride, or vinylidene chloride, or acrylonitrile, or 1-butene,or butadiene, or methacrylonitrile, or vinyltoluene, or vinyl ethylether, or perfluorohexylethylthiocarbonylaminoethyl methacrylate, orisobornyl methacrylate, or trifluoroethyl methacrylate, orhexafluoroisopropyl methacrylate, or hexafluorobutyl methacrylate, orethylene glycol methyl ether methacrylate (EGMA), or any combinationthereof. In one particular example, the hydrophobic monomer or monomercomponent can comprise or consist of methyl methacrylate, or ethyleneglycol methyl ether methacrylate, or both.

When present in the polymerizable composition, the hydrophobic monomeror monomer component can be present in an amount from about 5 to about25 unit parts, or from about 10 to about 20 unit parts.

In one example, the hydrophobic monomer component can comprise at leasttwo hydrophobic monomers each having different polymerizable functionalgroups. In another example, the hydrophobic monomer component cancomprise at least two hydrophobic monomers each having the samepolymerizable functional group. The hydrophilic monomer component cancomprise or consist of two hydrophobic monomers, both having the samepolymerizable functional group. In one example, the hydrophilic monomercomponent can comprise or consist of two hydrophobicmethacrylate-containing monomers. The hydrophilic monomer component cancomprise or consist of MMA and EGMA. In one example, the at least twohydrophobic monomers of the hydrophobic monomer component can compriseor consist of MMA and EGMA, and the ratio of the amounts of MMA and EGMApresent in the polymerizable composition can be from about 6:1 to about1:1 based on the unit parts of MMA to the unit parts of EGMA. The ratioof the unit parts of MMA and EGMA present in the polymerizablecomposition can be about 2:1 based on the unit parts of MMA to the unitparts of EGMA.

Optionally, the polymerizable composition can further comprise at leastone cross-linking agent. The polymerizable composition can comprise onecross-linking agent, or can comprise a cross-linking agent componentcomprised of at least two cross-linking agents. As used herein, across-linking agent is a non-silicon cross-linking agent and thus isdifferent from multifunctional siloxane monomers which may be present inthe polymerizable compositions.

In accordance with the present disclosure, a cross-linking agent isunderstood to be a monomer having more than one polymerizable functionalgroup as part of its molecular structure, such as two or three or fourpolymerizable functional groups, i.e., a multifunctional monomer such asa bifunctional or trifunctional or tetrafunctional monomer. Non-siliconcross-linking agents that can be used in the polymerizable compositionsdisclosed herein include, for example, without limitation, allyl(meth)acrylate, or lower alkylene glycol di(meth)acrylate, or poly(loweralkylene) glycol di(meth)acrylate, or lower alkylene di(meth)acrylate,or divinyl ether, or divinyl sulfone, or di- and trivinylbenzene, ortrimethylolpropane tri(meth)acrylate, or pentaerythritoltetra(meth)acrylate, or bisphenol A di(meth)acrylate, ormethylenebis(meth)acrylamide, or triallyl phthalate and diallylphthalate, or any combination thereof. Cross-linking agents, asdisclosed in the Examples, include, for example, ethylene glycoldimethacrylate (EGDMA), or triethylene glycol dimethacrylate (TEGDMA),or triethylene glycol divinyl ether (TEGDVE), or any combinationthereof. In one example, the cross-linking agent can have a molecularweight less than 1500 daltons, or less than 1000 daltons, or less than500 daltons, or less than 200 daltons.

In one example, the cross-linking agent can be a vinyl-containingcross-linking agent. As used herein, a vinyl-containing cross-linkingagent is a monomer having at least two polymerizable carbon-carbondouble bonds (i.e., at least two vinyl polymerizable functional groups)present in its molecular structure, where each of the at least twopolymerizable carbon-carbon double bonds present in the vinylpolymerizable functional groups of the vinyl-containing cross-linkingagent is less reactive than a carbon-carbon double bond present in anacrylate or methacrylate polymerizable functional group. Althoughcarbon-carbon double bonds are present in acrylate and methacrylatepolymerizable functional groups, as understood herein, cross-linkingagents comprising one or more acrylate or methacrylate polymerizablegroup (e.g., an acrylate-containing cross-linking agent or amethacrylate-containing cross-linking agent) are not considered to bevinyl-containing cross-linking agents. Polymerizable functional groupshaving carbon-carbon double bonds which are less reactive than thecarbon-carbon double bonds of acrylate or methacrylate polymerizablegroups include, for example, vinyl amide, vinyl ester, vinyl ether andallyl ester polymerizable functional groups. Thus, as used herein,vinyl-containing cross-linking agents include, for example,cross-linking agents having at least two polymerizable functional groupsselected from a vinyl amide, a vinyl ether, a vinyl ester, an allylester, and any combination thereof. As used herein, a mixedvinyl-containing cross-linking agent is a cross-linking agent having atleast one polymerizable carbon-carbon double bond (i.e., at least onevinyl polymerizable functional group) present in its structure which isless reactive than the carbon-carbon double bond present in an acrylateor methacrylate polymerizable functional group, and at least onepolymerizable functional group present in its structure having acarbon-carbon double bond which is at least as reactive as thecarbon-carbon double bond in an acrylate or methacrylate polymerizablefunctional group.

In one example, the cross-linking agent or cross-linking agent componentcan comprise a vinyl-containing cross-linking agent. For example, thevinyl-containing cross-linking agent or cross-linking agent componentcan comprise or consist of a vinyl ether-containing cross-linking agent.In another example, the cross-linking agent or cross-linking agentcomponent can comprise or consist of an acrylate-containingcross-linking agent (i.e., a cross-linking agent having at least twoacrylate polymerizable functional groups), or a methacrylate-containingcross-linking agent (i.e., at least two methacrylate polymerizablefunctional groups), or at least one acrylate-containing cross-linkingagent and at least one methacrylate-containing cross-linking agent.

The cross-linking agent component can comprise or consist of acombination of two or more cross-linking agents, each of which has adifferent polymerizable functional group. For example, the cross-linkingagent component can comprise one vinyl-containing cross-linking agent,and one acrylate-containing cross-linking agent. The cross-linking agentcomponent can comprise one vinyl-containing cross-linking agent and onemethacrylate-containing cross-linking group. The cross-linking agentcomponent can comprise or consist of one vinyl ether-containingcross-linking agent, and one methacrylate-containing cross-linkingagent.

Optionally, the polymerizable composition of the present disclosure cancomprise or consist of at least one vinyl-containing cross-linking agentor cross-linking agent component, and can be free of a non-siliconvinyl-free cross-linking agent. In other words, in this example, thepolymerizable composition comprises the first siloxane monomer, thesecond siloxane monomer, and at least one cross-linking agent, whereinthe at least one cross-linking agent consists of at least onevinyl-containing cross-linking agent (i.e., a single vinyl-containingcross-linking agent or a vinyl-containing cross-linking agent componentcomprised of two or more vinyl-containing cross-linking agents), as nonon-silicone cross-linking agents other than vinyl-containingcross-linking agents are present in the polymerizable composition. Inother words, in this example, no non-vinyl cross-linking agents arepresent in the polymerizable composition.

The optional cross-linking agent or cross-linking agent component can bepresent in the polymerizable composition in an amount from 0.01 to 10.0unit parts, such as, for example, from 0.05 to 5.0 unit parts, or from0.1 to 2.0 unit parts, or from 0.2 to 1.0 unit parts, or from 0.3 to 0.8unit parts. In one example, when the cross-linking agent orcross-linking agent component comprises a vinyl-containing cross-linkingagent, the vinyl-containing cross-linking agent or cross-linking agentcomponent can be present in the polymerizable composition in an amountfrom 0.01 to 0.80 unit parts, such as, for example, 0.05 to 0.30 unitparts or from 0.1 to 0.2 unit parts. When the at least one cross-linkingagent is a acrylate-containing or methacrylate-containing cross-linkingagent or cross-linking agent component, the acrylate-containing ormethacrylate-containing cross-linking agent or cross-linking agentcomponent can be present in the polymerizable composition in an amountfrom 0.1 to 2.0 unit parts, such as, for example, 0.3 to 1.2 unit partsor from 0.5 to 0.8 unit parts. When a combination of a vinyl-containingcross-linking agent or cross-linking agent component, and anacrylate-containing or methacrylate-containing cross-linking agent orcross-linking agent component is used, the vinyl-containingcross-linking agent or cross-linking agent component and theacrylate-containing or methacrylate-containing cross-linking agent orcross-linking agent component can be present in the polymerizablecomposition in a ratio from 1:2 to 1:20, or from 1:3 to 1:12, or from1:4 to 1:7 based on the ratio by weight of the unit parts of thevinyl-containing cross-linking agent or cross-linking agent component tothe unit parts of the acrylate-containing or methacrylate-containingcross-linking agent or cross-linking component.

While in some polymerizable compositions limiting the amount ofvinyl-containing cross-linking agent can improve wettability, in manycases, the inclusion of a vinyl-containing cross-linking agent in thepolymerizable composition can also improve the dimensional stability ofthe resulting contact lens formed from the polymerizable composition.Thus, in some polymerizable compositions, a vinyl-containingcross-linking agent can be present in the polymerizable in an amounteffective to produce a contact lens having improved dimensionalstability as compared to a contact lens produced from the samepolymerizable composition but without the vinyl-containing cross-linkingagent.

Yet another approach for producing contact lenses having ophthalmicallyacceptably wettable surfaces in accordance with the present disclosure,can be to include an amount of a vinyl-containing cross-linking agent inthe polymerizable composition based on the ratio of the unit parts ofthe hydrophilic vinyl-containing monomer present in the composition tothe unit parts of the vinyl-containing cross-linking agent present inthe composition. For example, the unit parts of the hydrophilicvinyl-containing monomer and the unit parts of the vinyl-containingcross-linking agent can be present in the polymerizable composition in aratio greater than about 125:1, or from about 150:1 to about 625:1, orfrom about 200:1 to about 600:1, or from about 250:1 to about 500:1, orfrom about 450:1 to about 500:1, based on the ratio of the unit parts ofthe hydrophilic vinyl-containing monomer to the unit parts of thevinyl-containing cross-linking agent.

The polymerizable composition can optionally include one or more organicdiluents, one or more polymerization initiators (i.e., ultraviolet (UV)initiators or thermal initiators, or both), or one or more UV absorbingagents, or one or more tinting agents, or one or more oxygen scavengers,or one or more chain transfer agents, or any combination thereof. Theseoptional ingredients can be reactive or non-reactive ingredients. In atleast one example, the polymerizable compositions can be diluent-free inthat they do not contain any organic diluent to achieve miscibilitybetween the siloxanes and the other lens forming ingredients, such asthe optional hydrophilic monomers, hydrophobic monomer, andcross-linking agents. In addition, many of the present polymerizablecompositions are essentially free of water (e.g., contain no more than3.0% or 2.0% water by weight).

The polymerizable compositions disclosed herein can optionally compriseone or more organic diluents, i.e., the polymerizable composition cancomprise an organic diluent, or can comprise an organic diluentcomponent comprising two or more organic diluents. Organic diluents thatcan optionally be included in the present polymerizable compositionsinclude alcohols, including lower alcohols, such as, for example,without limitation, pentanol, or hexanol, or octanol, or decanol, or anycombination thereof. When included, the organic diluent or organicdiluent component can be provided in the polymerizable composition in anamount from about 1 to about 70 unit parts, or from about 2 unit partsto about 50 unit parts, or from about 5 unit parts to about 30 unitparts.

Approaches commonly employed to increase the miscibility of siloxanemonomers and hydrophilic monomers include adding organic diluents to thepolymerizable composition to act as compatiblizers between thehydrophilic monomers and the siloxane monomers which typically are morehydrophobic, or using only siloxane monomers having low molecularweights (e.g., molecular weights below 2500 daltons). The use of thefirst siloxane as described above makes it possible to include both ahigh molecular weight second siloxane and a high level of one or morehydrophilic monomers in the polymerizable compositions of the presentdisclosure. And while it is possible to include one or more organicdiluents in the present polymerizable compositions disclosed herein, itmay not be necessary to do so in order to obtain a misciblepolymerizable composition in accordance with the present disclosure. Inother words, in at least one example, the silicone hydrogel contactlenses of the present disclosure are formed from polymerizablecompositions which are free of an organic diluent.

An example of the disclosed polymerizable composition can be misciblewhen initially prepared, and can remain miscible over a period of timeadequate for the commercial manufacture of contact lenses, such as, forexample, 2 weeks, or 1 week, or 5 days. Typically, when polymerized andprocessed into contact lenses, miscible polymerizable compositionsresult in contact lenses having ophthalmically acceptable clarities.

The present polymerizable compositions can optionally comprise one ormore polymerization initiators, i.e., the polymerizable composition cancomprise an initiator, or can comprise an initiator component comprisingtwo or more polymerization initiators. Polymerization initiators thatcan be included in the present polymerizable compositions include, forexample, azo compounds, or organic peroxides, or both. Initiators thatcan be present in the polymerizable composition include, for example,without limitation, benzoin ethyl ether, or benzyl dimethyl ketal, oralpha, alpha-diethoxyacetophenone, or 2,4,6-trimethylbenzoyl diphenylphosphine oxide, or benzoin peroxide, or t-butyl peroxide, orazobisisobutyronitorile, or azobisdimethylvaleronitorile, or anycombination thereof. UV photoinitiators can include, for example,phosphine oxides such as diphenyl (2,4,6-trimethyl benzoyl) phosphineoxide, or benzoin methyl ether, or 1-hydroxycyclohexylphenyl ketone, orDarocur (available from BASF, Florham Park, N.J., USA), or Irgacur (alsoavailable from BASF), or any combination thereof. In many of Examplesdisclosed herein, the polymerization initiator is the thermal initiator2,2′-azobis-2-methyl propanenitrile (VAZO-64 from E.I. DuPont de Nemours& Co., Wilmington, Del., USA). Other commonly used thermoinitiators caninclude 2,2′-azobis(2,4-dimethylpentanenitrile) (VAZO-52) and 1,1′-azobis(cyanocyclohexane) (VAZO-88). The polymerization initiator orinitiator component can be present in the polymerizable composition inan amount from about 0.01 unit parts to about 2.0 unit parts, or in anamount from about 0.1 unit parts to about 1.0 unit parts, or from about0.2 unit parts to about 0.6 unit parts by weight.

Optionally, the present polymerizable compositions can comprise one ormore UV absorbing agents, i.e., the polymerizable composition cancomprise an UV absorbing agent, or can comprise an UV absorbing agentcomponent comprising two or more UV absorbing agents. UV absorbingagents that can be included in the present polymerizable compositionsinclude, for example, benzophenones, or benzotriazoles, or anycombination thereof. In many of the Examples disclosed herein, the UVabsorbing agent is 2-(4-Benzoyl-3-hydroxyphenoxy)ethyl acrylate (UV-416)or 2-(3-(2H-benzotriazol-2-YL)-4-hydroxy-phenyl)ethyl methacrylate(NORBLOC® 7966 from Noramco, Athens, Ga., USA). The UV absorbing agentor UV absorbing agent component can be present in the polymerizablecomposition in an amount from about 0.01 unit parts to about 5.0 unitparts, or in an amount from about 0.1 unit parts to about 3.0 unitparts, or from about 0.2 unit parts to about 2.0 unit parts by weight.

The polymerizable compositions of the present disclosure can alsooptionally include at least one tinting agent (i.e., one tinting agentor a tinting agent component comprising two or more tinting agents),although both tinted and clear lens products are contemplated. In oneexample, the tinting agent can be a reactive dye or pigment effective toprovide color to the resulting lens product. The tinting agent ortinting agent component of the polymerizable composition can comprise apolymerizable tinting agent, or can comprise a non-polymerizable tintingagent, or any combination thereof. The polymerizable tinting agent canbe a tinting agent whose molecular structure comprises a polymerizablefunctional group, or can be a tinting agent whose molecular structureincludes both a monomer portion and a dye portion, i.e., the tintingagent can be a monomer-dye compound. Tinting agents can include, forexample, VAT Blue 6(7,16-Dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone), or1-Amino-4-[3-(beta-sulfatoethylsulfonyl)anilio]-2-anthraquinonesulfonicacid (C. I. Reactive Blue 19, RB-19), or a monomer-dye compound ofReactive Blue 19 and hydroxyethylmethacrylate (RB-19 HEMA), or1,4-bis[4-[(2-methacryl-oxyethyl)phenylamino]anthraquinone (ReactiveBlue 246, RB-246, available from Arran Chemical Company, Athlone,Ireland), or 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedionebis(2-propenoic)ester (RB-247), or Reactive Blue 4, RB-4, or amonomer-dye compound of Reactive Blue 4 and hydroxyethyl methacrylate(RB-4 HEMA or “Blue HEMA”), or any combination thereof. In one example,the tinting agent or tinting agent component can comprise apolymerizable tinting agent. The polymerizable tinting agent componentcan comprise, for example, RB-246, or RB-274, or RB-4 HEMA, or RB-19HEMA, or any combination thereof. Examples of monomer-dye compoundsinclude RB-4 HEMA and RB-19 HEMA. Additional examples of monomer-dyecompounds are described in U.S. Pat. No. 5,944,853 and U.S. Pat. No.7,216,975, both of which are incorporated in their entirety by referenceherein. Other exemplary tinting agents are disclosed, for example, inU.S. Patent Application Publication No. 2008/0048350, the disclosure ofwhich is incorporated in its entirety herein by reference. In many ofthe Examples disclosed herein, the tinting agent is a reactive blue dye,such as those described in U.S. Pat. No. 4,997,897, the disclosure ofwhich is incorporated in its entirety herein by reference. Othersuitable tinting agents for use in accordance with the present inventionare phthalocyanine pigments such as phthalocyanine blue, orphthalocyanine green, or chromic-alumina-cobaltous oxide, or chromiumoxides, or various iron oxides for red, yellow, brown and black colors,or any combination thereof. Opaquing agents such as titanium dioxide canalso be incorporated. For certain applications, a combination of tintingagents having different colors can be employed as the tinting agentcomponent. If employed, the tinting agent or tinting agent component canbe present in the polymerizable composition in an amount ranging fromabout 0.001 unit parts to about 15.0 unit parts, or about 0.005 unitparts to about 10.0 unit parts, or about 0.01 unit parts to about 8.0unit parts.

The polymerizable compositions of the present disclosure can optionallycomprise at least one oxygen scavenger, i.e., one oxygen scavenger or anoxygen scavenger component comprising two or more oxygen scavengers.Examples of oxygen scavengers which can be included as the oxygenscavenger or oxygen scavenger component of the present polymerizablecompositions include, for example, Vitamin E, or phenolic compounds, orphosphite compounds, or phosphine compounds, or amine oxide compounds,or any combination thereof. For example, the oxygen scavenger or oxygenscavenger component can consist of or comprise a phosphine-containingcompound. In many of the Examples disclosed herein, the oxygen scavengeror oxygen scavenger component is a phosphine-containing compound, suchas triphenyl phosphine, or a polymerizable form of triphenyl phosphine,such as diphenyl(P-vinylphenyl)phosphine.

Chain transfer is a polymerization reaction in which the activity of agrowing polymer chain is transferred to another molecule, reducing theaverage molecular weight of the final polymer. The polymerizablecompositions of the present disclosure can optionally comprise at leastone chain transfer agent, i.e., can comprise one chain transfer agent orcan comprise a chain transfer agent component comprising at least twochain transfer agents. Examples of chain transfer agents which can beincluded as the chain transfer agent or the chain transfer component ofthe present polymerizable compositions include, for example, thiolcompounds, or halocarbon compounds, or C3-C5 hydrocarbons, or anycombination thereof. In many of the Examples disclosed herein, the chaintransfer agent is allyloxy ethanol. When present in the polymerizablecomposition, the chain transfer agent or chain transfer agent componentcan be present in an amount from about 0.01 unit parts to about 1.5 unitparts, for example from about 0.1 unit parts to about 0.5 unit parts.

In one example, the silicone hydrogel contact lenses of the presentdisclosure can have relatively high equilibrium water contents (EWC)s.Methods of determining EWC are known to those of ordinary skill in theart, and can be based on weight loss from a lens during a dryingprocess. For example, the silicone hydrogel contact lenses can have,when fully hydrated, an equilibrium water content from 20% to 75% byweight. The present contact lenses can have an EWC from about 30% toabout 70%, or from about 45% to about 65%, or from about 50% to about63%, or from about 50% to about 67%, or from about 55% to about 65% byweight.

The present contact lenses can have an oxygen permeability (or Dk) of atleast 55 barrers (Dk≧55 barrers), or an oxygen permeability of at least60 barrers (Dk≧60 barrers), or an oxygen permeability of at least 65barrers (Dk≧65 barrers). The lenses can have an oxygen permeability fromabout 55 barrers to about 135 barrers, or from about 60 barrers to about120 barrers, or from about 65 barrers to about 90 barrers, or from about50 barrers to about 75 barrers. Various methods of determining oxygenpermeability are known to those of ordinary skill in the art.

The silicone hydrogel contact lenses of the present disclosure have,when fully hydrated, an average tensile modulus about 0.20 MPa to about0.90 MPa. For example, the average modulus can be from about 0.30 MPa toabout 0.80 MPa, or from about 0.40 MPa to about 0.75 MPa, or from about0.50 MPa to about 0.70 MPa.

As used herein, the modulus of a contact lens or lens body is understoodto refer to the tensile modulus, also known as Young's modulus. It is ameasure of the stiffness of an elastic material. The tensile modulus canbe measured using a method in accordance with ANSI Z80.20 standard. Inone example, the tensile modulus can be measured using an Instron Model3342 or Model 3343 mechanical testing system.

The present contact lenses can have an oxygen permeability of at least55 barrers (Dk≧55 barrers), or an EWC from about 30% to about 70%, or atensile modulus from about 0.2 MPa to about 0.9 MPa, or any combinationthereof. In one example, the contact lenses can have an oxygenpermeability of at least 60 barrers (Dk≧60 barrers), or an EWC fromabout 35% to about 65%, or a tensile modulus from about 0.3 MPa to about0.8 MPa, or any combination thereof. In another example, the presentcontact lenses can have an oxygen permeability of at least 60 barrers,or an EWC from about 45% to about 65%, or a tensile modulus from about0.40 MPa to about 0.75 MPa, or any combination thereof.

In one example, the present contact lenses have an oxygen permeabilityof at least 55 barrers, an EWC from about 30% to about 70%, and atensile modulus from about 0.2 MPa to about 0.9 MPa.

The silicone hydrogel contact lenses of the present disclosure can have,when fully hydrated, an average percentage of energy loss from about 25%to about 40%. For example, the average percentage of energy loss can befrom about 27% to about 40%, or can be from about 30% to about 37%.

As used herein, percentage of energy loss is a measure of the energylost as heat when energy loading and unloading cycles are applied toviscoelastic materials. Percentage of energy loss can be determinedusing a number of methods known to those of ordinary skill in the art.For example, the force involved in stretching a sample to 100% strain,and then returning it to 0% at a constant rate can be determined andused to calculate the percentage energy loss for the material.

The present contact lenses can have an ionoflux less than about 8.0×10⁻³mm²/min, or less than about 7.0×10⁻³ mm²/min, or less than about5.0×10⁻³ mm²/min. Various methods of determining ionoflux areconventional and are known to those of ordinary skill in the art.

Silicone hydrogel contact lenses of the present invention can havecaptive bubble dynamic advancing contact angles of less than 120degrees, such as, for example, less than 90 degrees when fully hydrated,less than 80 degrees when fully hydrated, less than 70 degrees whenfully hydrated, or less than 65 degrees when fully hydrated, or lessthan 60 degrees when fully hydrated, or less than 50 degrees when fullyhydrated.

Silicone hydrogel contact lenses of the present invention can havecaptive bubble static contact angles of less than 70 degrees when fullyhydrated, or less than 60 degrees when fully hydrated, or less than 55degrees when fully hydrated, or less than 50 degrees when fullyhydrated, or less than 45 degrees when fully hydrated.

In one example, the present contact lenses can have a wet extractablecomponent. The wet extractable component is determined based on theweight lost during methanol extraction of contact lenses which have beenfully hydrated and sterilized prior to drying and extraction testing.The wet extractable component can comprise unreacted or partiallyreacted polymerizable ingredients of the polymerizable composition. Asthe wet extractable component consists of extractable materialsremaining in the lens body after the lens body has been fully processedto form a sterilized contact lens, for lenses formed from polymerizablecompositions comprising non-reactive ingredients, it can be assumed thatsubstantially all of the non-reactive ingredients have been removed fromthe lens body during its processing, and so the wet extractablecomponent consists essentially of extractable components formed fromreactive ingredients of the polymerizable composition, i.e., unreactedpolymerizable components and partially reacted polymerizableingredients. In lenses made from a polymerizable composition free of adiluent, the wet extractable component can be present in the contactlens in an amount from about 1% wt/wt to about 15% wt/wt, or from about2% wt/wt to about 10% wt/wt, or from about 3% wt/wt to about 8% wt/wtbased on the dry weight of the lens body prior to extraction testing. Inlenses made from a polymerizable composition comprising a diluent, thewet extractable component may consist of a portion of the diluent aswell as unreacted and partially reacted polymerizable ingredients, andcan be present in the contact lens in an amount from about 1% wt/wt toabout 20% wt/wt, or from about 2% wt/wt to about 15% wt/wt of the lens,or from about 3% wt/wt to about 10% wt/wt based on the dry weight of thelens body prior to extraction testing.

In one example, the present contact lenses have a dry extractablecomponent. The dry extractable component is determined based on theweight lost during extraction in methanol of polymeric lens bodies whichhave not been washed, extracted (as part of a manufacturing process),hydrated or sterilized prior to the drying and extraction testing. Thedry extractable component can comprise unreacted or partially reactedpolymerizable ingredients of the polymerizable composition. Whenoptional non-reactive ingredients such as diluents and the like arepresent in the polymerizable composition, the dry extractable componentmay further comprise the non-reactive ingredients.

In lenses made from a polymerizable composition free of a diluent, thedry extractable component of the lens consists primarily of dryextractable components contributed by polymerizable ingredients of thepolymerizable composition (i.e., unreacted or partially reactedpolymerizable ingredients), and may also include dry extractablematerials contributed by optional non-polymerizable components presentin the polymerizable composition in small amounts (e.g., less than 3%wt/wt), such as, for example, initiators, tinting agents, oxygenscavengers, and the like. In lenses made from a polymerizablecomposition free of a diluent, the dry extractable component can bepresent in the polymeric lens body in an amount from about 1% wt/wt toabout 30% wt/wt of the lens body, or from about 2% wt/wt to about 25%wt/wt, or from about 3% wt/wt to about 20% wt/wt, or from about 4% wt/wtto about 15% wt/wt, or from 2% wt/wt to less than 10% wt/wt based on thedry weight of the lens body prior to extraction testing.

In lenses made from a polymerizable composition comprising a largeamount (e.g., more than 3% wt/wt) of an optional non-reactive ingredientsuch as a diluent, the dry extractable component consists of extractablematerials contributed by reactive ingredients as well as extractablecomponents contributed by non-polymerizable ingredients of thepolymerizable composition. The total amount of dry extractablecomponents contributed by reactive ingredients and non-polymerizableingredients present in the contact lens can consist of an amount fromabout 1% wt/wt to about 75% wt/wt, or from about 2% wt/wt to about 50%wt/wt of the lens, or from about 3% wt/wt to about 40% wt/wt, or fromabout 4% wt/wt to about 20% wt/wt, or from about 5% to about 10% basedon the dry weight of the polymeric lens body prior to extractiontesting. The total amount of dry extractable components contributed bypolymerizable ingredients (i.e., unreacted or partially reactedpolymerizable ingredients) can be an amount from about 1% wt/wt to about30% wt/wt of the lens body, or from about 2% wt/wt to about 25% wt/wt,or from about 3% wt/wt to about 20% wt/wt, or from about 4% wt/wt toabout 15% wt/wt, or from 2% wt/wt to less than 10% wt/wt based on thedry weight of the lens body prior to extraction testing.

The contact lenses of the present disclosure, as they are configured tobe placed or disposed on a cornea of an animal or human eye, areophthalmically acceptable contact lenses. As used herein, anophthalmically acceptable contact lens is understood to be a contactlens having at least one of a number of different properties asdescribed below. An ophthalmically acceptable contact lens can be formedof, and packaged in, ophthalmically acceptable ingredients such that thelens is not cytotoxic and does not release irritating and/or toxicingredients during wear. An ophthalmically acceptable contact lens canhave a level of clarity in the optic zone of the lens (i.e., the portionof the lens providing vision correction) sufficient for its intended usein contact with the cornea of an eye, for example, a transmittance of atleast 80%, or at least 90%, or at least 95% of visible light. Anophthalmically acceptable contact lens can have sufficient mechanicalproperties to facilitate lens handling and care for a duration of timebased on its intended lifetime. For example, its modulus, tensilestrength, and elongation can be sufficient to withstand insertion, wear,removal and, optionally, cleaning over the intended lifetime of thelens. The level of these properties which are appropriate will varydepending upon the intended lifetime and usage of the lens (e.g., singleuse daily disposable, multiple use monthly, etc). An ophthalmicallyacceptable contact lens can have an effective or appropriate ionoflux tosubstantially inhibit or substantially prevent corneal staining, such ascorneal staining more severe than superficial or moderate cornealstaining after continuous wear of the lens on a cornea for 8 or morehours. An ophthalmically acceptable contact lens can have a level ofoxygen permeability sufficient to allow oxygen to reach the cornea of aneye wearing the lens in an amount sufficient for long term cornealhealth. An ophthalmically acceptable contact lens can be a lens whichdoes not cause substantial or undue corneal swelling in an eye wearingthe lens, for example, no more than about 5% or 10% corneal swellingafter being worn on a cornea of an eye during an overnight sleep. Anophthalmically acceptable contact lens can be a lens which allowsmovement of the lens on the cornea of an eye wearing the lens sufficientto facilitate tear flow between the lens and the eye, in other words,does not cause the lens to adhere to the eye with sufficient force toprevent normal lens movement, and that has a low enough level ofmovement on the eye to allow vision correction. An ophthalmicallyacceptable contact lens can be a lens which allows wearing of the lenson the eye without undue or significant discomfort and/or irritationand/or pain. An ophthalmically acceptable contact lens can be a lenswhich inhibits or substantially prevents lipid and/or protein depositionsufficient to cause the lens wearer to remove the lens because of suchdeposits. An ophthalmically acceptable contact lens can have at leastone of a water content, or a surface wettability, or a modulus or adesign, or any combination thereof, that is effective to facilitateophthalmically compatible wearing of the contact lens by a contact lenswearer at least for one day. Ophthalmically compatible wearing isunderstood to refer to the wearing of a lens by a lens wearer withlittle or no discomfort, and with little or no occurrence of cornealstaining. Determining whether a contact lens is ophthalmicallyacceptable can be achieved using conventional clinical methods, such asthose performed by an eye care practitioner, and as understood bypersons of ordinary skill in the art.

The present contact lenses have ophthalmically acceptably wettable lenssurfaces. For example, the contact lenses can have the ophthalmicallyacceptably wettable lens surfaces when the polymerizable compositionused to form the polymeric lens body is free of an internal wettingagent, or when the polymerizable composition used to form the polymericlens body is free of an organic diluent, or when the polymeric lens bodyis extracted in water or an aqueous solution free of a volatile organicsolvent, or when the polymeric lens body is free of a surface plasmatreatment, or any combination thereof.

One approach commonly used in the art to increase the wettability ofcontact lens surfaces is to apply treatments to the lens surfaces or tomodify the lens surfaces. In accordance with the present disclosure, thesilicone hydrogel contact lenses can have ophthalmically acceptablywettable lens surfaces without the presence of a surface treatment orsurface modification. Surface treatments include, for example, plasmaand corona treatments which increase the hydrophilicity of the lenssurface. While it is possible to apply one or more surface plasmatreatments to the present lens bodies, it is not necessary to do so inorder to obtain a silicone hydrogel contact lens having ophthalmicallyacceptably wettable lens surfaces when fully hydrated. In other words,in one example, the silicone hydrogel contact lenses of the presentdisclosure can be can be free of a surface plasma or corona treatment.

Surface modifications include binding wetting agents to the lenssurface, such as, for example, binding a wetting agent such as ahydrophilic polymer to at least a lens surface by chemical bonding oranother form of chemical interaction. In some cases, the wetting agentmay be bound to the lens surface as well as a least a portion of thepolymeric matrix of the lens, i.e., at least a portion of the bulk ofthe lens, by chemical bonding or another form of chemical interaction.The ophthalmically acceptably wettable lens surfaces of the presentdisclosure can be ophthalmically acceptably wettable without thepresence of a wetting agent (e.g., a polymeric material or anon-polymeric material) bound to at least the lens surface. While it ispossible to bind one or more wetting agents to the present lenses, it isnot necessary to do so in order to obtain a silicone hydrogel contactlens having ophthalmically acceptably wettable lens surfaces when fullyhydrated. Thus, in one example, the lenses of the present disclosure cancomprise wetting agents, such as, for example, hydrophilic polymers andincluding polyvinyl pyrrolidone, bound to a surface of the lens.Alternatively, in another example, the silicone hydrogel contact lensesof the present disclosure can be free of a wetting agent bound to thelens surface.

Another method of increasing lens wettability is to physically entrap awetting agent within the lens body or contact lens, such as byintroducing the wetting agent into the lens body when the lens body isswollen, and then returning the lens body to a less swollen state,thereby entrapping a portion of a wetting agent within the lens body.The wetting agent can be permanently trapped within the lens body, orcan be released from the lens over time, such as during wear. Theophthalmically acceptably wettable lens surfaces of the presentdisclosure can be ophthalmically acceptably wettable without thepresence of a wetting agent (e.g., a polymeric material or anon-polymeric material) physically entrapped in the lens body followingformation of the polymeric lens body. While it is possible to physicallyentrap one or more wetting agents in the present lenses, it is notnecessary to do so in order to obtain a silicone hydrogel contact lenshaving ophthalmically acceptably wettable lens surfaces when fullyhydrated. Thus, in one example, the lenses of the present disclosure cancomprise wetting agents, such as, for example, hydrophilic polymers andincluding polyvinyl pyrrolidone, entrapped within the lenses.Alternatively, the silicone hydrogel contact lenses of the presentdisclosure can be free of a wetting agent physically entrapped withinthe lens. As used herein, physically entrapped refers to immobilizing awetting agent, or other ingredient, in the polymeric matrix of the lenswith little or no chemical bonding or chemical interaction being presentbetween the wetting agent and or other ingredient and the polymericmatrix. This is in contrast to ingredients that are chemically bound tothe polymeric matrix, such as by ionic bonds, covalent bonds, van derWaals forces, and the like.

Another approach commonly used in the art to increase the wettability ofsilicone hydrogel contact lenses includes adding one or more wettingagents to the polymerizable composition. In one example, the wettingagent can be a polymeric wetting agent. However, the contact lenses ofthe present disclosure can have ophthalmically acceptably wettable lenssurfaces when the polymerizable composition used to form the polymericlens body is free of a wetting agent. While it is possible to includeone or more wetting agents in the present polymerizable compositions toincrease the wettability of the silicone hydrogel contact lenses of thepresent disclosure, it is not necessary to do so in order to obtain asilicone hydrogel contact lens having ophthalmically acceptably wettablelens surfaces. In other words, in one example, the silicone hydrogelcontact lenses of the present disclosure can be formed frompolymerizable compositions free of wetting agents. Alternatively, inanother example, the polymerizable compositions of the present inventioncan further comprise a wetting agent.

In one example, the wetting agent can be an internal wetting agent. Theinternal wetting agent can be bound within at least a portion of thepolymeric matrix of the lens. For example, the internal wetting agentcan be bound within at least a portion of the polymeric matrix of thelens by chemical bonding or another form of chemical interaction. Insome cases, the wetting agent may be bound to the lens surface as well.The internal wetting agent can comprise a polymeric material or anon-polymeric material. While it is possible to bind one or moreinternal wetting agents within the polymeric matrix of the presentlenses, it is not necessary to do so in order to obtain a siliconehydrogel contact lens having ophthalmically acceptably wettable lenssurfaces when fully hydrated. Thus, in one example, the lenses of thepresent disclosure can comprise internal wetting agents bound to atleast a portion of the polymeric matrix of the lens. Alternatively, inanother example, the silicone hydrogel contact lenses of the presentdisclosure can be free of an internal wetting agent bound to at least aportion of the polymeric matrix of the lens.

In another example, the wetting agent can be an internal polymericwetting agent. The internal polymeric wetting agent can be present inthe polymeric lens body as part of an interpenetrating polymer network(IPN) or a semi-IPN. An interpenetrating polymer network is formed by atleast two polymers, each of which is crosslinked to itself, but none ofwhich are crosslinked to each other. Similarly, a semi-IPN is formed byat least two polymers, at least one of which is crosslinked to itselfbut not to the other polymer, and the other of which is not crosslinkedeither to itself or the other polymer. In one example of the presentdisclosure, the contact lens can have ophthalmically acceptably wettablelens surfaces when the polymeric lens body is free of an internalpolymeric wetting agent present in the lens body as an IPN or asemi-IPN. Alternatively, the contact lens can comprise an internalpolymeric wetting agent present in the lens body as an IPN or asemi-IPN.

In yet another example, the wetting agent can be a linking compoundpresent in the polymerizable composition used to form the lens body, ora linking agent physically entrapped within the polymeric lens bodyafter the lens body has been formed. When the wetting agent is a linkingcompound, after polymerization of the lens body or entrapment of thelinking agent in the polymeric lens body, the linking compound cansubsequently link a second wetting agent to the lens body when the lensbody is contacted by the wetting agent. The linking can occur as part ofthe manufacturing process, for example as a washing process, or can takeplace when the lens body is contacted by a packaging solution. Thelinking can take the form of an ionic bond, or a covalent bond, or aform of van der Waals attraction. The linking agent can comprise aboronic acid moiety or group such that a polymerized boronic acid moietyor group is present in the polymeric lens body, or such that a boronicacid moiety or group is physically entrapped in the polymeric lens body.For example, when the linking agent comprises a form of boronic acid,the second wetting agent can comprise a form of poly(vinyl alcohol)which becomes bound to the form of boronic acid. Optionally, siliconehydrogel contact lenses of the present disclosure can be understood tobe free of linking agents. In one example, the silicone hydrogel contactlenses can be free of boronic acid moieties or groups, includingpolymerized boronic acid moieties or groups, that is, specifically, thesilicone hydrogel contact lenses can be formed from a polymerizablecomposition free of a form of boronic acid such as, for example, apolymerizable form of boronic acid including vinyl phenyl boronic acid(VPB), can be formed of a polymer free of units derived from apolymerizable form of boronic acid such as vinyl phenyl boronic acid(VPB), and the polymeric lens body and the silicone hydrogel contactlenses can be free of a form of boronic acid, including polymeric ornon-polymeric form of boronic acid, physically entrapped therein.Alternatively, the polymerizable composition, or the polymeric lensbody, or the silicone hydrogel contact lens, or any combination thereof,can comprise at least one linking agent.

The silicone hydrogel contact lenses of the present disclosure have notbeen exposed to a volatile organic solvent or a solution of a volatileorganic solvent as part of a manufacturing process. In one example, thesilicone hydrogel contact lenses of the present disclosure can be formedfrom a polymerizable composition free of a wetting agent, or thepolymeric lens body and/or hydrated contact lens can be free of awetting agent, or free of surface treatment, or free of a surfacemodification, or was not exposed to a volatile organic solvent or asolution of a volatile organic solvent during the manufacturing process,or any combination thereof. Instead, for example, the silicone hydrogelcontact lenses can be extracted in water or an aqueous solution free ofa volatile organic solvent, such as, for example, free of a volatilelower alcohol.

The use of volatile organic solvents to extract lens bodies contributessignificantly to production costs, due to factors such as the cost ofthe organic solvents, the cost of disposal of the solvents, the need toemploy explosion-proof production equipment, the need to remove thesolvents from the lenses prior to packaging, and the like. However,development of polymerizable compositions capable of consistentlyproducing contact lenses with ophthalmically acceptably wettable lenssurfaces when extracted in aqueous liquids free of volatile organicsolvents can be challenging. For example, it is common to findnon-wetting regions present on the lens surfaces of contact lenses whichhave been extracted in aqueous liquids free of volatile organicsolvents, as discussed herein.

As previously discussed, the contact lenses disclosed herein are contactlenses which have not been exposed to a volatile organic solvent, suchas a lower alcohol, during their manufacture. In other words, theextraction liquids used for such lenses, as well as all liquids usedduring wet demolding, or wet delensing, or washing, or any othermanufacturing step, are all free of volatile organic solvents. In oneexample, the polymerizable composition used to form these entirelyaqueous liquid extracted lenses can comprise a hydrophilicvinyl-containing monomer or monomer component, such as, for example, ahydrophilic vinyl ether-containing monomer. The vinyl-containinghydrophilic monomer or monomer component can include, for example, VMA.The vinyl ether-containing monomers can include, for example, BVE, orEGVE, or DEGVE, or any combination thereof. In one particular example,the vinyl ether-containing monomer can be a vinyl ether-containingmonomer which is more hydrophilic than BVE, such as, for example, DEGVE.In another example, the hydrophilic monomer component of thepolymerizable composition can be a mixture of a first hydrophilicmonomer which is a vinyl-containing monomer but which is not a vinylether-containing monomer, and a second hydrophilic monomer which is avinyl ether-containing monomer. Such mixtures include, for example,mixtures of VMA and one or more vinyl ethers such as, for example, BVE,or DEGVE, or EGVE, or any combination thereof.

When present, the hydrophilic vinyl ether-containing monomer or monomercomponent can be present in the polymerizable composition in an amountfrom about 1 to about 15 unit parts, or from about 3 to about 10 unitparts. When present as a mixture with a hydrophilic vinyl-containingmonomer which is not a vinyl ether, the portion of the hydrophilicvinyl-containing monomer or monomer component which is not a vinyl etherand the hydrophilic vinyl ether-containing monomer or monomer componentcan be present in the polymerizable composition at a ratio of at least3:1, or from about 3:1 to about 15:1, or of about 4:1 based on the ratioof the unit parts by weight of the hydrophilic vinyl-containing monomeror monomer component which is not a vinyl ether to the unit parts byweight of the hydrophilic vinyl ether-containing monomer or monomercomponent.

Another approach for producing contact lenses having ophthalmicallyacceptably wettable lens surfaces in accordance with the presentdisclosure, particularly lenses extracted in a liquid free of a volatileorganic solvent, can be to limit the amount of a vinyl-containingcross-linking agent or cross-linking agent component included in thepolymerizable composition. For example, a vinyl-containing cross-linkingagent or cross-linking agent component can be present in thepolymerizable composition in an amount from about 0.01 to about 0.80unit parts, or from 0.05 to about 0.30 unit parts, or from about 0.05 toabout 0.20 unit parts, or in an amount of about 0.1 unit parts. In oneexample, a vinyl-containing cross-linking agent or cross-linking agentcomponent can be present in the polymerizable composition in an amounteffective to produce a contact lens having improved wettability ascompared to a contact lens produced from the same polymerizablecomposition but having an amount of the vinyl-containing cross-linkingagent or cross-linking agent component greater than about 2.0 unitparts, or greater than 1.0 unit parts, or greater than about 0.8 unitparts, or greater than about 0.5 unit parts, or greater than about 0.3unit parts.

Certain specific examples of silicone hydrogel contact lenses will nowbe described, in accordance with the present teachings.

As one example (example A), a silicone hydrogel contact lens comprises apolymeric lens body that is the reaction product of a polymerizablecomposition comprising a first monofunctional siloxane monomer, such asthe siloxane monomer represented by formula (1), wherein m of formula(1) represents one integer from 3 to 10, n of formula (1) represents oneinteger from 1 to 10, R¹ of formula (1) is an alkyl group having from 1to 4 carbon atoms, and each R² of formula (1) is independently either ahydrogen atom or a methyl group; a second siloxane monomer having morethan one polymerizable functional group and that has a number averagemolecular weight of at least 3,000 daltons; and a hydrophilic amidemonomer or monomer component having one N-vinyl group, specifically thehydrophilic monomer comprises or consists of N-vinyl-N-methyl acetamide(VMA), wherein the first siloxane monomer and second siloxane monomerare present in the composition at a ratio of 2:1 based on unit parts byweight.

One example of a method of manufacturing a batch of silicone hydrogelcontact lenses of the present disclosure is a method comprising:providing polymerized silicone hydrogel contact lens bodies in contactlens mold assemblies, the polymerized silicone hydrogel contact lensbodies being the reaction product of a polymerizable compositioncomprising a first monofunctional siloxane monomer, a second siloxanemonomer having more than one polymerizable functional group and that hasa number average molecular weight of at least 3,000 daltons, and ahydrophilic amide monomer or monomer component having one N-vinyl group,the first siloxane monomer and second siloxane monomer are present inthe composition at a ratio of 2:1 based on unit parts by weight, whereina single polymerized silicone hydrogel contact lens body is provided ina single contact lens mold assembly, and each contact lens mold assemblycomprises a first mold section having a concave optical surface forforming an anterior surface of the silicone hydrogel contact lens bodyand a second mold section having a convex optical surface for forming aposterior surface of the silicone hydrogel contact lens body, and thefirst mold section and second mold section are coupled together;separating the polymerized silicone hydrogel contact lens bodies fromthe contact lens mold assemblies to produce delensed contact lensbodies; washing the delensed contact lens bodies with an aqueous liquidfree of volatile organic solvent to produce washed contact lenses; andsterilizing the washed contact lenses in sealed contact lens packages;wherein the batch so manufactured comprises at least twenty siliconehydrogel contact lenses, and the anterior surfaces of the sterilizedcontact lenses have clinically acceptable surface wettabilities suchthat less than five percent of the silicone hydrogel contact lenses havevisually identifiable non-wetting spots when located on eyes ofsubjects, and wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the contact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×. In oneexample, the at least one hydrophilic vinyl-containing monomer ormonomer component can comprise a hydrophilic amide monomer having oneN-vinyl group can comprise N-vinyl-N-methyl acetamide (VMA), or thefirst siloxane monomer can comprise a siloxane monomer represented byformula (1) as discussed above, or both. In another example, thepolymerizable composition can be free of a diluent, or free of ahydrophilic polymer, or free of N,N-dimethylacrylamide (DMA), or anycombination thereof. In yet another example, the silicone hydrogelcontact lens can be free of a plasma surface treatment or of a polymericinternal wetting agent provided by including a hydrophilic polymer in apolymerizable composition used to form the silicone hydrogel contactlens, or both.

One example of a batch of silicone hydrogel contact lenses in accordancewith the present disclosure is a batch comprising: at least twentypolymerized silicone hydrogel contact lenses, the polymerized siliconehydrogel contact lenses being the reaction product of a polymerizablecomposition comprising a first monofunctional siloxane monomer, a secondsiloxane monomer having more than one polymerizable functional group andthat has a number average molecular weight of at least 3,000 daltons,and a hydrophilic amide monomer or monomer component having one N-vinylgroup, the first siloxane monomer and second siloxane monomer arepresent in the composition at a ratio of 2:1 based on unit parts byweight, each silicone hydrogel contact lens of the batch being anaqueous extracted silicone hydrogel contact lens comprising an anteriorsurface and an opposing posterior surface, the posterior surfacedimensioned (sized and shaped) for placement against a subject's eye;the anterior surface of each of the aqueous extracted contact lenseshaving a clinically acceptable surface wettability, such that less thanfive percent of the batch of silicone hydrogel contact lenses hasvisually identifiable non-wetting spots when located on eyes of subject;wherein the non-wetting spots are discontinuities of the contact lenswearer's pre-lens tear film present on the anterior surface of the lensbody, and are visually identifiable during a slit lamp examination at atotal magnification from about 6× to about 70×. In one example, the atleast one hydrophilic vinyl-containing monomer or monomer component cancomprise a hydrophilic amide monomer having one N-vinyl group cancomprise N-vinyl-N-methyl acetamide (VMA), or the first siloxane monomercan comprise a siloxane monomer represented by formula (1) as discussedabove, or both. In another example, the polymerizable composition can befree of a diluent, or free of a hydrophilic polymer, or free ofN,N-dimethylacrylamide (DMA), or any combination thereof. In yet anotherexample, the silicone hydrogel contact lens can be free of a plasmasurface treatment or of a polymeric internal wetting agent provided byincluding a hydrophilic polymer in a polymerizable composition used toform the silicone hydrogel contact lens, or both.

As a second example (example B), a silicone hydrogel contact lenscomprises a polymeric lens body that is the reaction product of apolymerizable composition as described in example A, and wherein thepolymerizable composition further comprises a hydrophobic monomer ormonomer component, specifically the hydrophilic monomer comprises orconsists of methyl methacrylate (MMA).

As a third example (example C), a silicone hydrogel contact lenscomprises a polymeric lens body that is the reaction product of apolymerizable composition as described in example A or B, and whereinthe polymerizable composition further comprises a vinyl ether-containingcross-linking agent or cross-linking agent component, specifically thecross-linking agent or cross-linking agent component comprises orconsists of triethylene glycol divinyl ether (TEGVE).

As a fourth example (example D), a silicone hydrogel contact lenscomprises a polymeric lens body that is the reaction product of apolymerizable composition as described in example A or B or C, andwherein the polymerizable composition further comprises a thermalinitiator or thermal initiator component.

As a fifth example (example E), a silicone hydrogel contact lenscomprises a polymeric lens body that is the reaction product of apolymerizable composition as described in example A or B or C or D, andwherein the polymerizable composition further comprises an oxygenscavenger or oxygen scavenger component.

As a sixth example (example F), a silicone hydrogel contact lenscomprises a polymeric lens body that is the reaction product of apolymerizable composition as described in example A or B or C or D or E,and wherein the polymerizable composition further comprises a UV blockeror UV blocker component.

As a seventh example (example G), a silicone hydrogel contact lenscomprises a polymeric lens body that is the reaction product of apolymerizable composition as described in example A or B or C or D or Eor F, and wherein the polymerizable composition further comprises atinting agent or tinting agent component.

As an eighth example (example H), a silicone hydrogel contact lenscomprises a polymeric lens body that is the reaction product of apolymerizable composition as described in example A or B or C or D or Eor F or G, and wherein the second siloxane monomer is represented byformula (2), wherein R₁ of formula (2) is selected from either hydrogenatom or a methyl group; R₂ of formula (2) is selected from either ofhydrogen or a hydrocarbon group having 1 to 4 carbon atoms; m of formula(2) represents an integer of from 0 to 10; n of formula (2) representsan integer of from 4 to 100; a and b represent integers of 1 or more;a+b is equal to 20-500; b/(a+b) is equal to 0.01-0.22; and theconfiguration of siloxane units includes a random configuration. As oneexample, the second siloxane monomer can be represented by formula (2),wherein m of formula (2) is 0, n of formula (2) is one integer from 5 to10, a is one integer from 65 to 90, b is one integer from 1 to 10, R₁ offormula (2) is a methyl group, and R₂ of formula (2) is either ahydrogen atom or a hydrocarbon group having 1 to 4 carbon atoms.

As a ninth example (example I), a silicone hydrogel contact lenscomprises a polymeric lens body that is the reaction product of apolymerizable composition as described in example A or B or C or D or Eor F or G or H, and wherein the polymerizable composition furthercomprises a methacrylate-containing cross-linking agent or cross-linkingagent component, specifically the cross-linking agent or agent componentcomprises or consists of ethylene glycol dimethacrylate (EGDMA). In thisexample, when the polymerizable composition also comprises a vinylether-containing cross-linking agent as part of the cross-linking agentcomponent, specifically the cross-linking agent component can compriseor consist of triethylene glycol divinyl ether (TGDVE) in combinationwith a methacrylate-containing cross-linking agent, which canspecifically comprise or consist of ethylene glycol dimethacrylate(EGDMA). In this example, it can be appreciated that the polymerizablecomposition comprises two cross-linking agents, each having differentreactivity ratios, i.e., the polymerizable composition comprises across-linking agent component comprising or consisting of avinyl-containing cross-linking agent and a methacrylate-containingcross-linking agent, the methacrylate-containing cross-linking agenthaving polymerizable functional groups which are more reactive and whichthus react at a faster rate than the vinyl polymerizable functionalgroups present in the vinyl-containing cross-linking agent.

As a tenth example (example J), a silicone hydrogel contact lenscomprises a polymeric lens body that is the reaction product of apolymerizable composition as described in example A or B or C or D or Eor F or G or H or I, and wherein the polymerizable composition furthercomprises a chain transfer agent or chain transfer agent component whichcan specifically comprise or consist of allyloxy ethanol (AE).

As an eleventh example (example K), a silicone hydrogel contact lenscomprises a polymeric lens body that is the reaction product of apolymerizable composition as described in example A or B or C or D or Eor F or G or H or I or J, and wherein the polymerizable compositionfurther comprises a hydrophobic monomer or hydrophobic monomer componentwhich can specifically comprise or consist of ethylene glycol methylether methacrylate (EGMA).

As a twelfth example (example L), a silicone hydrogel contact lenscomprises a polymeric lens body that is the reaction product of apolymerizable composition as described in example A or B or C or D or Eor F or G or H or I or J or K, and wherein the polymerizable compositionfurther comprises a hydrophilic vinyl ether-containing monomer ormonomer component, for example, the hydrophilic vinyl ether-containingmonomer or monomer component can comprise or consist of 1,4-butanediolvinyl ether (BVE), or ethylene glycol vinyl ether (EGVE), or diethyleneglycol vinyl ether (DEGVE), or any combination thereof.

In any or each of the foregoing examples A-L, as well as any or allother examples disclosed herein, the amount of the first siloxanemonomer can be from 20 to 45 unit parts of the polymerizablecomposition. The amount of the first siloxane monomer can be from 25 to40 unit parts of the polymerizable composition. The amount of the firstsiloxane monomer can be from 27 to 35 unit parts of the polymerizablecomposition.

In any or each of the foregoing examples A-L, as well as any or allother examples disclosed herein, the amount of the second siloxanemonomer can be from 1 to 20 unit parts of the polymerizable composition,as long as the ratio of 2:1 based on unit parts by weight of the firstsiloxane to the second siloxane is maintained. The amount of the secondsiloxane monomer can be from 2 to 15 unit parts of the polymerizablecomposition. The amount of the second siloxane monomer can be from 5 to13 unit parts of the polymerizable composition.

In any or each of the foregoing examples A-L, as well as any or allother examples disclosed herein, the amount of the hydrophilic monomeror monomer component present in the polymerizable composition can befrom 1 to 60 unit parts of the polymerizable composition. Thehydrophilic monomer component can constitute from 4 to 60 unit parts ofthe polymerizable composition. When the hydrophilic monomer comprises orconsists of the VMA, it can be present in an amount from 30 unit partsto 60 unit parts. VMA can be present in the polymerizable composition inan amount from about 40 unit parts to about 50 unit parts. When thehydrophilic monomers, N,N-dimethylacrylamide (DMA), 2-hydroxyethylmethacrylate (HEMA), or 2-hydroxylbutyl methacrylate (HOB), or anycombination thereof are present in the polymerizable composition as thehydrophilic monomer in the hydrophilic monomer component, each or allcan be present in amounts from about 3 to about 10 unit parts.

In any or each of the foregoing examples A-L as well as any or all otherexamples disclosed herein, the amount of the hydrophobic monomer ormonomer component present in the polymerizable composition can be from 1to 30 unit parts of the polymerizable composition. For example, thetotal amount of hydrophobic monomer or monomer component can be fromabout 5 to about 20 unit parts of the polymerizable composition. Inpolymerizable compositions in which the hydrophobic monomer MMA ispresent as the hydrophobic monomer or as part of the hydrophobic monomercomponent, the MMA can be present in an amount from about 5 to about 20unit parts, or from about 8 to about 15 unit parts.

In any or each of the foregoing examples A-L, as well as any or allother examples disclosed herein, the amount of the cross-linking agentor cross-linking agent component present in the polymerizablecomposition can be from 0.01 to 4 unit parts of the polymerizablecomposition. TEGDVE can be present in amounts from 0.01 to 1.0 unitparts. EGDMA can be present in amounts from 0.01 to 1.0 unit parts.TEGDMA can be present in amounts from 0.1 to 2.0 unit parts. Each ofthese non-silicon cross-linking agents can be present alone or in anycombination in the polymerizable composition.

In any or each of the foregoing examples A-L, as well as any or allother examples disclosed herein, when the polymerizable compositioncontains EGMA, BVE, DEGVE, EGVE, or any combination thereof, they areeach present in amounts from 1 unit part to 20 unit parts of thepolymerizable composition. EGMA can be present in an amount from about 2unit parts to about 15 unit parts. BVE can be present in an amount from1 unit part to about 15 unit parts. BVE can be present in an amount fromabout 3 unit parts to about 7 unit parts. DEGVE can be present in anamount from 1 unit part to about 15 unit parts. DEGVE can be present inan amount from about 7 unit parts to about 10 unit parts. EGVE can bepresent in an amount from 1 unit part to about 15 unit parts, or in anamount from about 3 unit parts to about 7 unit parts.

In any or each of the foregoing examples A-L, as well as any or allother examples disclosed herein, the other optional components, such asinitiators or initiator component, tinting agents or tinting agentcomponents, UV absorbing agents or UV absorbing agent components, oxygenscavengers or oxygen scavenger components, or chain transfer agents orchain transfer agent components, can each be present in amounts fromabout 0.01 unit parts to about 3 unit parts. An initiator or initiatorcomponent can be present in the polymerizable in an amount from 0.1 unitparts to 1.0 unit parts. When a thermal initiator or thermal initiatorcomponent is present, such as Vazo-64, it can be present in an amountfrom about 0.3 to about 0.5 unit parts. Tinting agents or tinting agentcomponents can be present in amounts from 0.01 unit parts to 1 unitpart. When reactive dyes are used as tinting agents or as part of atinting agent component, such as Reactive Blue 246 or Reactive Blue 247,they can each be present in amounts of about 0.01 unit parts. UVabsorbing agents or UV absorbing agent components can be present inamounts from 0.1 unit parts to 2.0 unit parts. For example, the UVabsorbing agent UV1 described in the Examples below can be present in anamount from about 0.8 to about 1.0 unit parts, such as 0.9 unit parts;or the UV absorbing agent UV2 described in the Examples below, can bepresent in an amount from 0.5 unit parts to 2.5 unit parts, such as fromabout 0.9 unit parts to about 2.1 unit parts. Oxygen scavengers oroxygen scavenger components can be present in amounts from 0.1 unitparts to 1.0 unit parts. As an example, when triphenyl phosphine (TPP)or diphenyl(P-vinylphenyl)phosphine (pTPP) or any combination thereof isused as an oxygen scavenger or oxygen scavenger component in thepolymerizable composition, each or the combination can be present in anamount from 0.3 unit parts to 0.7 unit parts, such as about 0.5 unitparts. Chain transfer reagents or chain transfer reagent components canbe present in the polymerizable composition in an amount from 0.1 unitparts to 2.0 unit parts, and in many of the Examples below is present inan amount from 0.2 unit parts to 1.6 unit parts. For example, the chaintransfer reagent allyloxy ethanol (AE) can be present in an amount fromabout 0.3 to about 1.4 unit parts.

In any or each of the foregoing examples A-L, as well as any or allother examples disclosed herein, the silicone hydrogel contact lensescan be free of a wetting agent that is present in the polymerizablecomposition, or in the polymeric lens body, or in the silicone hydrogelcontact lens. Similarly, the silicone hydrogel contact lens can havelens surfaces that are free of a surface treatment or a surfacemodification. However, in another example, the silicone hydrogel contactlens can include at least one wetting agent (i.e., a single wettingagent or two or more wetting agents present as a wetting agentcomponent) in the polymerizable composition, in the polymeric lens body,or in the silicone hydrogel contact lens. The silicone hydrogel contactlens can have treated or modified lens surfaces. In addition oralternatively, any or each of the foregoing examples A-L, as well as anyor all other examples of silicone hydrogel contact lenses disclosedherein, the contact lenses can be understood to be free of a linkingagent such as, for example, a form of boronic acid.

In another example, new polymerizable compositions are provided,including each and every polymerizable composition described herein inreference to the silicone hydrogel contact lenses and methods. Thepolymerizable compositions can be diluent-free in that they do notcontain an organic solvent, such as alcohols and the like, which canhelp reduce phase separation of the polymerizable composition. However,such diluent-free polymerizable compositions can still contain one ormore chain transfer agents, such as allyloxy ethanol. However, ifdesired, the polymerizable composition can include a diluent or adiluent component, which can be present in an amount from 1 to 20 unitparts.

As described herein, the present silicone hydrogel contact lenses whichcomprise polymeric lens bodies that comprise units derived from a firstsiloxane monomer represented by formula (1) and a second siloxanemonomer having more than one polymerizable functional group and having anumber average molecular weight of at least 3,000 daltons, such as thoserepresented by formulas (2), (3), or (4), are dimensionally stable. Thepresent disclosure also relates to a batch of silicone hydrogel contactlenses.

As used herein, a batch of silicone hydrogel contact lenses refers to agroup of twenty or more silicone hydrogel contact lenses, andfrequently, a batch refers to at least 20, or at least 100, or at least1,000 silicone hydrogel contact lenses. In accordance with the presentdisclosure, a batch of silicone hydrogel contact lenses comprises atleast 20 of any of the silicone hydrogel contact lenses describedherein.

When initially tested shortly after manufacturing and then tested againat a later time point, a batch of lenses can exhibit a change in itsaverage physical dimensions. As batches of lenses in accordance with thepresent disclosure are dimensionally stable, they can exhibit anacceptable level of change in their average physical dimensions. As usedherein, dimensional stability variance is understood to refer to avariance in a value of a physical dimension between a value of thephysical dimension determined when the batch of lenses is initiallytested shortly after its manufacture, and the value of the physicaldimension determined when the batch of lenses is tested again at a latertime point. The later time point can be, for example, from at least 2weeks after the initial time point, to up to 7 years after the initialtime point. The silicone hydrogel contact lenses of the batch have anaverage dimensional stability variance of less than plus or minus threepercent (±3.0%) based on averaging the lens diameter measurements of arepresentative number of lenses from the batch, such as, for example, 20lenses from the batch. For a batch of lenses, an average dimensionalstability variance of less than plus or minus three percent (±3.0%),where the average dimensional stability variance is the variance in avalue of a physical dimension when measured at an initial time pointwithin one day of a manufacturing date of the batch of lenses, and at asecond time point, where the second time point is from two weeks toseven years after the initial time point when the batch is stored atroom temperature, or, when the batch is stored at a higher temperature(i.e., under accelerated shelf life testing conditions), the second timepoint is a time point representative of storage of the batch from twoweeks to seven years at room temperature, is considered to be adimensionally stable batch. In one example, accelerated shelf lifetesting conditions which are especially useful in determining averagedimensional stability variance are for 4 weeks at 70 degrees C.,although other periods of time and other temperatures can be used. Theaverage dimensional stability variance is determined by averaging theindividual dimensional stability variances for each of therepresentative lenses using the actual diameters of representativelenses measured initially (Diameter_(Original)) and the actual diametersof representative lenses measured following (Diameter_(Final)) storageat room temperature or under accelerated shelf life conditions. Therepresentative lenses measured initially and the representative lensesmeasured following storage can be the same lenses or can be differentlenses. As used herein, the average dimensional stability variance isrepresented as a percent (%). The individual dimensional stabilityvariances are determined using the following equation (A):((Diameter_(Final)−Diameter_(Original))/Diameter_(Original))×100  (A).

On average, the diameters of the silicone hydrogel contact lenses of thebatch vary by less than three percent in either direction of a targetvalue (±3.0%). As one example, if a contact lens has a target diameter(chord diameter) of 14.20 mm, the present batch of silicone hydrogelcontact lenses will have an average diameter (average of the populationin the batch) from 13.77 mm to 14.63 mm. In one example, the dimensionalstability variance is less than plus or minus two percent (±2.0%). Asone example, if a contact lens has a target diameter (chord diameter) of14.20 mm, the present batch of silicone hydrogel contact lenses willhave an average diameter (average of the population in the batch) from13.92 mm to 14.48 mm. Preferably, the average diameter of the batch ofsilicone hydrogel contact lenses does not vary by more than plus orminus 0.20 mm from the target diameter, which is commonly from 13.00 mmto 15.00 mm.

In accelerated shelf life studies, the average dimensional stabilityvariance can be determined for contact lenses that were stored for aperiod of time at an elevated temperature, such as above 40 degrees C.,including, for example, 50 degrees C., or 55 degrees C., or 65 degreesC., or 70 degrees C., or 80 degrees C., or 95 degrees C., and the like.Or, the average dimensional stability can be determined for contactlenses that were stored for a period of time at room temperature (e.g.,about 20-25 degrees C.).

For accelerated shelf life studies, the following formula can be used todetermine the number of months of storage at a particular temperaturethat are equivalent to storage for a desired length of time at roomtemperature:Desired shelf life=[N×2^(y) ]+n  (B)

where

N=number of months of storage under accelerated conditions

2^(y)=acceleration factor

y=(test temperature−25° C.)/10° C.

n=age of lenses (in months) at start of the study

Based on this equation, the following storage times have beencalculated: 6 months of storage at 35 degrees C. is equivalent to 1 yearaging at 25 degrees C., 3 months of storage at 45 degrees C. isequivalent to 1 year of aging at 25 degrees C., 3 months of storage at55 degrees C. is equivalent to 2 years of aging at 25 degrees C., and 3months of storage at 65 degrees C. is equivalent to 4 years of aging at25 degrees C.

As discussed herein, the present disclosure also provides methods ofmanufacturing silicone hydrogel contact lenses. In accordance with thepresent teachings, some of the present methods comprise providing apolymerizable composition. In some examples of the present methods, thepolymerizable composition, or contact lens formulation, comprises afirst siloxane monomer represented by formula (1):

wherein m of formula (1) represents one integer from 3 to 10, n offormula (1) represents one integer from 1 to 10, R¹ of formula (1) is analkyl group having from 1 to 4 carbon atoms, and each R² of formula (1)is independently either a hydrogen atom or a methyl group. Thepolymerizable composition also comprises a second siloxane monomerhaving more than one polymerizable functional group and having a numberaverage molecular weight of at least 3,000 daltons. The first siloxanemonomer and the second siloxane monomer are present in the polymerizablecomposition at a ratio of at least 2:1 based on unit parts. Thepolymerizable composition also comprises at least one hydrophilicmonomer, or at least one hydrophobic monomer, or at least onecross-linking agent, or any combination thereof.

The method can also comprise a step of polymerizing the polymerizablecomposition to form a polymeric contact lens body. The step ofpolymerizing the polymerizable composition can be conducted in a contactlens mold assembly. The polymerizable composition can be cast moldedbetween molds formed of a thermoplastic polymer. The thermoplasticpolymer used to form the molding surfaces of the mold can comprise apolar polymer, or can comprise a non-polar polymer. Alternatively, thepolymerizable composition can be formed into a lens via various methodsknown to those of ordinary skill in the art, such as spin casting,injection molding, forming a polymerized rod that is subsequently lathedto form a lens body, etc.

The method also comprises contacting the polymeric lens body with anaqueous washing liquid to remove extractable material, such as unreactedmonomers, uncross-linked materials that are otherwise not physicallyimmobilized in the polymeric contact lens body, diluents, and the like.

In accordance with the present disclosure, the polymeric contact lensbody can be packaged along with a contact lens packaging solution in acontact lens package, such as a blister pack or glass vial. Followingpackaging, the package can be sealed and the polymeric contact lens bodyand the contact lens packaging solution can be sterilized, for example,by autoclaving the sealed package, to produce a silicone hydrogelcontact lens product.

In the present methods, the step of contacting the polymeric contactlens body with a washing liquid can be understood to be an extractionstep because extractable materials can be removed from the polymericcontact lens body during the process. In the present methods, thecontacting step comprises contacting the polymeric contact lens bodywith an aqueous washing liquid that is free of a volatile organicsolvent. Such methods may be understood to be entirely aqueous washingsteps, as no volatile organic solvents are included in the washingliquid. Water-based washing liquids that can be used in such methodsinclude water, such as deionized water, saline solutions, bufferedsolutions, or aqueous solutions containing surfactants or othernon-volatile ingredients that can improve the removal of hydrophobiccomponents from the polymeric contact lens bodies, or can reducedistortion of the polymeric contact lens bodies, compared to the use ofdeionized water alone.

After washing, the contact lenses can be placed in packages, such asplastic blister packs, with a packaging solution, such as a bufferedsaline solution, which may or may not contain surfactants,anti-inflammatory agents, anti-microbial agents, contact lens wettingagents, and the like, and can be sealed and sterilized.

EXAMPLES

The following Examples illustrate certain aspects and advantages of thepresent invention, which should be understood not to be limited thereby.

As can be readily determined by a review of the Examples below, all ofthe Example formulations are free of an organic diluent. Also, all ofthe Example formulations are free of N,N-dimethylacrylamide (DMA).Additionally, all of the Example formulations below are free of apolymeric wetting agent. Furthermore, all of the Example formulationscomprise at least one hydrophilic amide monomer having one N-vinylgroup. A majority of the Example formulations comprise a second siloxanewhich is a dual-end methacrylate end-capped polydimethylsiloxane havinga number average molecular weight of at least 5,000 daltons.

The following chemicals are referred to in Examples C1 and 1-25, and maybe referred to by their abbreviations.

Si1: 2-propenoic acid, 2-methyl-,2-[3-(9-butyl-1,1,3,3,5,5,7,7,9,9-decamethylpentasiloxane-1-yl)propoxy]ethylester (CAS number of 1052075-57-6). (Si1 was obtained from Shin-EtsuChemical Co., Ltd., Tokyo, Japan, as product number X-22-1622).

Si2: α,ω-Bis(methacryloxypropyl)-poly(dimethylsiloxane)-poly(ω-methoxy-poly(ethylenegylcol)propylmethylsiloxane) (thesynthesis of this compound can be performed as described inUS20090234089, which is incorporated herein by reference)

Si3: Poly(dimethyl siloxane), methacryloxypropyl terminated (CAS number58130-03-3; DMS-R18 available from Gelest)

VMA: N-vinyl-N-methylacetamide (CAS number 003195786)

DMA: N,N-dimethylacrylamide (CAS number 2680-03-7)

HEMA: 2-hydroxyethyl methacrylate (CAS number 868-77-9)

HOB: 2-hydroxylbutyl methacylate (CAS number 29008-35-3)

EGMA: Ethylene glycol methyl ether methacrylate (CAS number 6976-93-8)

MMA: Methyl methacrylate (CAS number 80-62-6)

EGDMA: Ethylene glycol dimethacrylate (CAS number 97-90-5)

TEGDMA: triethylene glycol dimethacrylate (CAS number 109-16-0)

BVE: 1,4-butanediol vinyl ether (CAS number 17832-28-9)

DEGVE: diethylene glycol vinyl ether (CAS number 929-37-3)

EGVE: ethylene glycol vinyl ether (CAS number 764-48-7)

TEGDVE: triethylene glycol divinyl ether (CAS number 765-12-8)

AE: 2-Allyloxy ethanol (CAS number 111-45-5)

V-64: 2,2′-Azobis-2-methyl propanenitrile (CAS number 78-67-1)

UV1: 2-(4-benzoyl-3-hydroxyphenoxy)ethyl acrylate (CAS number16432-81-8)

UV2: 2-(3-(2H-benzotriazol-2-YL)-4-hydroxy-phenyl)ethyl methacrylate(CAS number 96478-09-0)

RBT1: 1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthroquinone (CASnumber 121888-69-5)

RBT2: 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedionebis(2-propenoic)ester (CAS Reg. No. 109561071)

TPP: Triphenyl phosphine (CAS number 603-35-0)

pTPP: polymerizable TPP: diphenyl(P-vinylphenyl)phosphine (CAS number40538-11-2)

Silicone Hydrogel Contact Lens Fabrication and Testing Procedure

The chemical compounds set forth in Examples were, for each example,weighed out in amounts corresponding to the described unit parts, andcombined to form a mixture. The mixture was filtered through a 0.2-5.0micron syringe filter into a bottle. Mixtures were stored for up toabout 2 weeks. The mixtures are understood to be polymerizable siliconehydrogel contact lens precursor compositions, or as used herein,polymerizable compositions. In the Examples, the listed amounts ofingredients are given as unit parts of the polymerizable composition byweight.

A volume of the polymerizable composition was cast molded by placing thecomposition in contact with a lens defining surface of a female moldmember. In all of the following Examples, the molding surface of thefemale mold member was formed of a non-polar resin, specificallypolypropylene, although polar resins, such as PBT could also be used. Amale mold member was placed in contact with the female mold member toform a contact lens mold assembly comprising a contact lens shapedcavity containing the polymerizable composition. In the followingExamples, the molding surface of the male mold member was formed of anon-polar resin, specifically polypropylene.

Contact lens mold assemblies were placed in a nitrogen flushed oven toallow the precursor compositions to thermally cure. For all of theExamples, the contact lens mold assemblies were exposed to temperaturesof at least about 55° C. for about 2 hours. Examples of curing profileswhich can be used to cure silicone hydrogel contact lenses describedherein include exposing the contact lens mold assemblies to temperaturesof 55° C. for 40 minutes, 80° C. for 40 minutes, and 100° C. for 40minutes. Other contact lenses can be made with the same curing profile,but instead of the first temperature being at 55° C., it can be at 65°C.

After polymerizing the polymerizable compositions, the contact lens moldassemblies were demolded to separate the male and female mold members.The polymerized contact lens body remained adhered to the male mold orthe female mold. A dry demolding process where the mold assembly is notcontacted with a liquid medium can be used, or a wet demolding processwhere the mold assembly is contacted with a liquid medium such as, forexample, water or an aqueous solution, can be used. A mechanical drydemolding process can involve applying mechanical force to a portion ofone or both of the mold members in order to separate the mold members.In all of the following Examples, a dry demolding process was used.

The polymerized contact lens body was then delensed from the male moldor female mold to produce a delensed polymerized contact lens body. Inone example of a delensing method, the polymerized contact lens body canbe delensed from the male mold member using a dry delensing process,such as by manually peeling the lens from the male mold member or bycompressing the male mold member and directing a gas toward the malemold member and the polymerized contact lens body, and lifting the drypolymerized contact lens body with a vacuum device from the male moldmember, which is discarded. In other methods, the polymerized contactlens body can be delensed using a wet delensing process by contactingthe dry polymerized contact lens body with a liquid releasing medium,such as water or an aqueous solution. For example, a male mold memberwith the attached polymerized contact lens body can be dipped into areceptacle containing a liquid until the polymerized contact lens bodyseparates from the male mold member. Or, a volume of liquid releasingmedium can be added to the female mold to soak the polymerized contactlens body in the liquid and to separate the lens body from the femalemold member. In the following Examples, a dry delensing process wasused. Following separation, the lens body can be lifted from the moldmember manually using tweezers or using a vacuum device and placed intoa tray.

The delensed lens product was then washed to remove extractablematerials from the polymerized contact lens body, and hydrated.Extractable materials included polymerizable components such as, forexample, monomers, or cross-linkers, or any optional polymerizableingredients such as tints or UV blockers, or combinations thereof,present in the polymerizable composition which remain present in thepolymeric lens body in an unreacted form, in a partially reacted form,or in an uncross-linked form, or any combination thereof, followingpolymerization of the lens body and prior to extraction of the lensbody. Extractable materials may have also included any non-polymerizableingredients present in the polymerizable composition, for example, anyoptional non-polymerizable tinting agents, or UV blockers, or diluents,or chain transfer agent, or any combination thereof, remaining presentin the polymeric lens body following polymerization of the polymericlens body but prior to extraction of the polymeric lens body.

In another method, such as a method involving delensing by compressionof the male mold member and directing gas flow toward the male moldmember, the delensed polymerized contact lens bodies can be placed incavities of lens carriers or trays where the delensed polymeric lensbodies can then be contacted with one or more volumes of an extractionliquid, such as an aqueous extraction liquid free of a volatile organicsolvent, for example deionized water or an aqueous solution of asurfactant such as Tween 80.

In other methods, such as those involving wet delensing by contactingthe mold and lens with a liquid releasing medium, the delensedpolymerized contact lens bodies can be washed to remove extractablecomponents from the lens bodies using a washing liquid that is free of avolatile organic solvent, such as a lower alcohol, for example,methanol, ethanol, or any combination thereof. For example, the delensedpolymerized contact lens bodies can be washed to remove extractablecomponents from the lens bodies by contacting the lens bodies withaqueous washing liquids free of a volatile organic solvent, such as, forexample, deionized water, or a surfactant solution, or a salinesolution, or a buffer solution, or any combination thereof. The washingcan take place in the final contact lens package, or can take place a inwashing tray or a washing tank.

In the following Examples, following the dry demolding and dry delensingsteps, the dry delensed lens bodies were placed in cavities of trays,and the delensed polymeric lens bodies were extracted and hydrated bycontacting the polymeric lens bodies with one or more volumes ofextraction liquids. The extraction and hydration liquids used in theextraction and hydration process consisted of volatile organicsolvent-free extraction and hydration liquids, i.e., entirelyaqueous-based extraction and hydration liquids. Specifically, in theExamples below, the extraction and hydration process used comprised atleast three extraction and hydration steps in separate portions of asolution of Tween 80 in deionized water, wherein the temperature of theTween 80 solution of the portions ranged from room temperature to about90 degrees C., and wherein each extraction and hydration step lastedfrom about 15 minutes to about 3 hours.

Washed, extracted and hydrated lenses were then placed individually incontact lens blister packages with a phosphate buffered saline packagingsolution. The blister packages were sealed and sterilized byautoclaving.

Following sterilization, lens properties such as contact angle,including dynamic and static contact angle, oxygen permeability,ionoflux, modulus, elongation, tensile strength, water content, and thelike were determined, as described herein.

For the present contact lenses, contact angles including dynamic andstatic contact angles, can be determined using routine methods known topersons of ordinary skill in the art. For example, the advancing contactangle and receding contact angle of the contact lenses provided hereincan be measured using a conventional drop shape method, such as thesessile drop method or captive bubble method.

In the following Examples, the advancing and receding contact angle ofsilicone hydrogel contact lenses was determined using a Kruss DSA 100instrument (Kruss GmbH, Hamburg), and as described in D. A. Brandreth:“Dynamic contact angles and contact angle hysteresis”, Journal ofColloid and Interface Science, vol. 62, 1977, pp. 205-212 and R.Knapikowski, M. Kudra: Kontaktwinkelmessungen nach demWilhelmy-Prinzip-Ein statistischer Ansatz zur Fehierbeurteilung”, Chem.Technik, vol. 45, 1993, pp. 179-185, and U.S. Pat. No. 6,436,481, all ofwhich are incorporated by reference herein.

As an example, the advancing contact angle and receding contact anglewas be determined using a captive bubble method using phosphate bufferedsaline (PBS; pH=7.2). The lens was flattened onto a quartz surface andrehydrated with PBS for at least 10 minutes before testing. An airbubble was placed onto a lens surface using an automated syringe system.The size of the air bubble was increased and decreased to obtain thereceding angle (the plateau obtained when increasing the bubble size)and the advancing angle (the plateau obtained when decreasing the bubblesize).

The modulus, elongation, and tensile strength values of the presentlenses can be determined using routine methods known to persons ofordinary skill in the art, such as, for example, a test method inaccordance with ANSI Z80.20. The modulus, elongation, and tensilestrength values reported herein were determined by using an InstronModel 3342 or 3343 mechanical testing system (Instron Corporation,Norwood, Mass., USA) and Bluehill Materials Testing Software, using acustom built rectangular contact lens cutting die to prepare therectangular sample strip. The modulus, elongation and tensile strengthwere determined inside a chamber having a relative humidity of least70%. The lens to be tested was soaked in phosphate buffered solution(PBS) for at least 10 minutes prior to testing. While holding the lensconcave side up, a central strip of the lens was cut using the cuttingdie. The thickness of the strip was determined using a calibrated gauge(Rehder electronic thickness gauge, Rehder Development Company, CastroValley, Calif., USA). Using tweezers, the strip was loaded into thegrips of the calibrated Instron apparatus, with the strip fitting overat least 75% of the grip surface of each grip. A test method designed todetermine the maximum load (N), the tensile strength (MPa), the strainat maximum load (% elongation) and the mean and standard deviation ofthe tensile modulus (MPa) was run, and the results were recorded.

The percent energy loss of the present silicone hydrogel contact lensescan be determined using routine methods known to persons of ordinaryskill in the art. For the following Examples, the percent energy losswas determined using an Instron Model 3343 (Instron Corporation,Norwood, Mass., USA) mechanical testing system, with a 10N forcetransducer (Instron model no. 2519-101) and Bluehill Materials TestingSoftware including a TestProfiler module. The energy loss was determinedinside a chamber having a relative humidity of least 70%. Beforetesting, each lens was soaked in phosphate buffered solution (PBS) forat least 10 minutes. Using tweezers, the lens was loaded into the gripsof the calibrated Instron apparatus, with the lens loaded verticallybetween the grips as symmetrically as possible so that the lens fit overat least 75% of the grip surface of each grip. A test designed todetermine the energy required to stretch the lens to 100% strain andthen return it to 0% strain at a rate of 50 mm/minute was then run onthe lens. The test was conducted only once on a single lens. Once thetest was finished, energy loss was calculated using the followingequation: Lost Energy (%)=(Energy to 100% strain−Energy to return to 0%strain)/Energy to 100% strain×100%.

The ionoflux of the present lenses can be determined using routinemethods known to persons of ordinary skill in the art. For the lenses ofthe following Examples, the ionoflux was measured using a techniquesubstantially similar to the “Ionoflux Technique” described in U.S. Pat.No. 5,849,811, which is incorporated by reference herein. Prior tomeasurement, a hydrated lens was equilibrated in deionized water for atleast 10 minutes. The lens to be measured was placed in a lens-retainingdevice, between male and female portions. The male and female portionsincluded flexible sealing rings which were positioned between the lensand the respective male or female portion. After positioning the lens inthe lens-retaining device, the lens-retaining device was then placed ina threaded lid. The lid was screwed onto a glass tube to define a donorchamber. The donor chamber was filled with 16 ml of 0.1 molar NaClsolution. A receiving chamber was filled with 80 ml of deionized water.Leads of the conductivity meter were immersed in the deionized water ofthe receiving chamber and a stir bar was added to the receiving chamber.The receiving chamber was placed in a water bath and the temperature washeld at about 35° C. Finally, the donor chamber was immersed in thereceiving chamber such that the NaCl solution inside the donor chamberwas level with the water inside the receiving chamber. Once thetemperature inside the receiving chamber was equilibrated to 35 degreesC., measurements of conductivity were taken every 2 minutes for at least10 minutes. The conductivity versus time data was substantially linear,and was used to calculate the ionoflux value for the lenses tested.

The oxygen permeability (Dk) of the present lenses can be determinedusing routine methods known to persons of ordinary skill in the art. Forexample, the Dk value can be determined using the Mocon Method, asdescribed in U.S. Pat. No. 5,817,924, which is incorporated by referenceherein. The Dk values of the lenses of the following Examples weredetermined using a commercially available instrument under the modeldesignation of MOCON® Ox-Tran System (Mocon Inc., Minneapolis, Minn.,USA).

The equilibrium water content (EWC) of the present lenses can bedetermined using routine methods known to persons of ordinary skill inthe art. For the lenses of the following Examples a hydrated siliconehydrogel contact lens was removed from an aqueous liquid, wiped toremove excess surface water, and weighed. The weighed lens was thendried in an oven at 80 degrees C. under a vacuum, and the dried lens wasthen weighed. The weight difference was determined by subtracting theweight of the dry lens from the weight of the hydrated lens. The watercontent (%) is the (weight difference/hydrated weight)×100.

The percentage of the wet extractable component or dry extractablecomponent in a lens can be determined by extracting the lenses in anorganic solvent in which the polymeric lens body is not soluble inaccordance to methods known to those of ordinary skill in the art. Forthe lenses of the following Examples, an extraction in methanol using aSohxlet extraction process was used. For determination of the wetextractable component, a sample (e.g., at least 5 lenses per lot) offully hydrated and sterilized contact lenses was prepared by removingexcess packaging solution from each lens and drying them overnight in an80° C. vacuum oven. For determination of the dry extractable component,a sample of polymeric lens bodies which had not been washed, extracted;hydrated or sterilized was prepared by drying the lens bodies overnightin an 80° C. vacuum oven. When dried and cooled, each lens was weighedto determine its initial dry weight (W1). Each lens was then placed in aperforated, stackable Teflon thimble, and the thimbles were stacked toform an extraction column with an empty thimble placed at the top of thecolumn. The extraction column was placed into a small Sohxlet extractorattached to a condenser and a round bottom flask containing 70-80 mlmethanol. Water was circulated through the condenser and the methanolwas heated until it gently boiled. The lenses were extracted for atleast 4 hours from the time condensed methanol first appeared. Theextracted lenses were again dried overnight at 80° C. in a vacuum oven.When dried and cooled, each lens was weighed to obtain the dry weight ofthe extracted lens (W2), and the following calculation was made for eachlens to determine the percent wet extractables: [(W1−W2)/W1]×100.

Example 1

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 32 Si3 4 VMA 40 EGMA 5 MMA 12TEGDMA 1.0 TEGDVE 0.3 BVE 7 V-64 0.5 UV2 0.9 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si3. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses had, when fullyhydrated, an EWC of about 55% wt/wt, an ionoflux from about 3.1 (×10⁻³mm²/min), a Dk of about 72 barrers, a modulus of about 0.70 MPa, anelongation of about 345%, a tensile strength of about 2.4 MPa, a waterbreak up time greater than 20 seconds, a wet extractable component ofabout 3.9% wt/wt, and an energy loss of about 40% when tested at thestart of the shelf life study, and had an average dimensional stabilityvariance less than plus or minus 3.0% after storage for more than 2weeks at 80 degrees C. When tested prior to extraction and hydration,the polymeric lens bodies had a dry extractable component of about 11%wt/wt.

Example 2

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 32 Si3 4 VMA 50 MMA 14 TEGDMA0.8 TEGDVE 0.2 V-64 0.5 UV2 0.9 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si3. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 58% wt/wt, an ionoflux from about 4.14(×10⁻³ mm²/min), a modulus of about 0.77 MPa, an elongation of about349%, a tensile strength of about 1.75 MPa, a water break up timegreater than 20 seconds, a wet extractable content of about 4.42% wt/wt,and an energy loss of about 41% when tested at the start of the shelflife study, and had an average dimensional stability variance less thanplus or minus 3.0% after storage for at least 2 weeks at 80 degrees C.

Example 3

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 23 Si2 15 VMA 40 MMA 10 EGMA5 BVE 7 TEGDMA 1.0 TEGDVE 0.1 V-64 0.5 UV2 0.9 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 55% wt/wt, an ionoflux from about 4.19(×10⁻³ mm²/min), a modulus of about 0.61 MPa, an elongation of about275%, a tensile strength of about 1.51 MPa, a water break up timegreater than 20 seconds, and a wet extractable component of about 4.10%wt/wt when tested at the start of the shelf life study, and had anaverage dimensional stability variance less than plus or minus 3.0% formore than 2 weeks at 80 degrees C.

Example 4

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 23 Si2 15 VMA 45 MMA 10 BVE 7TEGDMA 1.0 TEGDVE 0.1 V-64 0.5 UV2 0.9 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 58% wt/wt, an ionoflux from about 2.75(×10⁻³ mm²/min), a modulus of about 0.66 MPa, an elongation of about216%, a tensile strength of about 0.87 MPa, a water break up timegreater than 20 seconds, and a wet extractable component of about 4.56%wt/wt when tested at the start of the shelf life study, and had anaverage dimensional stability variance less than plus or minus 3.0%after storage for 6 days at 95 degrees C.

Example 5

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 26 Si2 10 VMA 40 MMA 12 EGMA5 BVE 7 TEGDMA 1.2 TEGDVE 0.1 V-64 0.5 UV2 0.9 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 56% wt/wt, an ionoflux from about 3.54(×10⁻³ mm²/min), a modulus of about 0.57 MPa, an elongation of about310%, a tensile strength of about 1.90 MPa, a water break up timegreater than 20 seconds, a wet extractable component of about 4.74%wt/wt, and an energy loss from about 34 to 36% when tested at the startof the shelf life study, and had an average dimensional stabilityvariance less than plus or minus 3.0% after storage for 7 days at 80degrees C. When tested prior to extraction and hydration, the polymericlens bodies had a dry extractable component of about 14.39% wt/wt.

Example 6

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 26 Si2 10 VMA 45 MMA 12 EGMA2 BVE 5 TEGDMA 1.2 TEGDVE 0.2 V-64 0.5 UV2 0.9 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 57% wt/wt, an ionoflux from about 3.68(×10⁻³ mm²/min), a modulus of about 0.69 MPa, an elongation of about314%, a tensile strength of about 1.30 MPa, a water break up timegreater than 20 seconds, a wet extractable component of about 1.81%wt/wt, and an energy loss of about 34% when tested at the start of theshelf life study, and had an average dimensional stability variance lessthan plus or minus 3.0% after storage for 14 days at 80 degrees C.

Example 7

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 26 Si3 2 Si2 10 VMA 45 MMA 12BVE 5 TEGDMA 1.2 TEGDVE 0.2 V-64 0.5 UV2 0.9 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom three siloxane monomers, Si1, Si2 and Si3. This batch of contactlenses had acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 55% wt/wt, an ionoflux from about 3.06(×10⁻³ mm²/min), a modulus of about 0.85 MPa, an elongation of about284%, a tensile strength of about 1.88 MPa, a water break up timegreater than 20 seconds, a wet extractable component of about 2.38%wt/wt, and an energy loss of about 36% when tested at the start of theshelf life study, and had an average dimensional stability variance lessthan plus or minus 3.0% after storage for 14 days at 80 degrees C.

Example 8

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 26 Si2 10 VMA 40 MMA 12 EGMA5 BVE 7 TEGDMA 1.3 TEGDVE 0.2 V-64 0.5 UV2 0.9 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 54% wt/wt, an ionoflux from about 3.57(×10⁻³ mm²/min), a modulus of about 0.66 MPa, an elongation of about274%, a tensile strength of about 1.40 MPa, and a wet extractablecontent of about 3.8% wt/wt when tested at the start of the shelf lifestudy, and had an average dimensional stability variance less than plusor minus 3.0% after storage for 7 days at 80 degrees C.

Example 9

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 26 Si3 2 Si2 10 VMA 45 MMA 12BVE 5 TEGDMA 1.1 TEGDVE 0.2 V-64 0.5 UV2 0.9 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom three siloxane monomers, Si1, Si2 and Si3. This batch of contactlenses had acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had a modulus of about 0.81 MPa, an elongation of about 351%,a tensile strength of about 1.61 MPa, and EWC from 30% wt/wt to 70%wt/wt when tested at the start of the shelf life study, and had anaverage dimensional stability variance less than plus or minus 3.0% for14 days at 80 degrees C.

Example 10

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 26 Si3 2 Si2 10 VMA 40 EGMA15 BVE 7 TEGDMA 1.6 TEGDVE 0.2 V-64 0.5 UV2 0.9 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an ionoflux from about 3.33 (×10⁻³ mm²/min), a modulus ofabout 0.74 MPa, and an elongation of about 222% when tested at the startof the shelf life study, and had an average dimensional stabilityvariance less than plus or minus 3.0% for 14 days at 80 degrees C.

Example 11

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 32 Si3 4 VMA 45 MMA 13 EGMA 3BVE 3 TEGDMA 1.0 TEGDVE 0.2 V-64 0.5 UV2 1.3 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si3. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 57% wt/wt, a modulus of about 0.70 MPa, anenergy loss of about 40%, and a captive bubble dynamic advancing contactangle of from about 50 to about 60 degrees when tested at the start ofthe shelf life study, and had an average dimensional stability varianceless than plus or minus 3.0% for 14 days at 80 degrees C.

Example 12

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 26 Si2 10 VMA 40 MMA 12 EGMA5 BVE 7 TEGDMA 1.2 TEGDVE 0.2 V-64 0.5 UV2 1.3 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 56% wt/wt, a modulus of about 0.50 MPa,and a captive bubble dynamic advancing contact angle of from about 47 toabout 51 degrees when tested at the start of the shelf life study, andhad an average dimensional stability variance less than plus or minus3.0% for 4.4 weeks at 80 degrees C.

Example 13

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 26 Si2 10 VMA 40 MMA 12 EGMA5 BVE 3 EGDMA 0.5 TEGDVE 0.1 V-64 0.5 UV2 1.3 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 55% wt/wt, a modulus of about 0.60 MPa,and a captive bubble dynamic advancing contact angle of from about 47 toabout 55 degrees when tested at the start of the shelf life study, andhad an average dimensional stability variance less than plus or minus3.0% after storage for 2 weeks at 80 degrees C.

Example 14

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 29 Si2 8 VMA 42 MMA 14 DEGVE7 EGDMA 0.6 TEGDVE 0.08 V-64 0.5 UV2 1.3 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC from about 55% wt/wt to about 56% wt/wt, a modulusof about 0.71 MPa, and a captive bubble dynamic advancing contact angleof from about 45 to about 47 degrees when tested at the start of theshelf life study, and had an average dimensional stability variance lessthan plus or minus 3.0% for at least 2 weeks at 80 degrees C.

Example 15

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 29 Si2 8 VMA 44 MMA 14 EGVE 5EGDMA 0.6 TEGDVE 0.15 V-64 0.5 UV2 1.3 RBT2 0.01

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 56% wt/wt, and a modulus of about 0.65 MPawhen tested at the start of the shelf life study, and had an averagedimensional stability variance less than plus or minus 3.0% for 2 weeksat 80 degrees C.

Example 16

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 29 Si2 8 VMA 45 MMA 13 HEMA 4EGDMA 0.5 TEGDVE 0.1 V-64 0.5 UV2 1.7 RBT2 0.01 pTPP 0.5 AE 0.3

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of from about 55% wt/wt to about 56% wt/wt, amodulus of about 0.53 MPa, a captive bubble dynamic advancing contactangle of from about 51 to about 53 degrees, and an energy loss of about34% when tested at the start of the shelf life study, and had an averagedimensional stability variance less than plus or minus 3.0% for 4.4weeks at 80 degrees C.

Example 17

A polymerizable silicone composition was obtained by mixing andfiltering the following chemical compounds in the specified amounts,using the procedure described in the Silicone Hydrogel Contact LensFabrication and Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 29 Si2 8 VMA 42 MMA 8 EGMA 6DEGVE 7 EGDMA 0.6 TEGDVE 0.1 V-64 0.5 UV2 1.7 RBT2 0.01 pTPP 0.5 AE 0.4

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC from 57% wt/wt to 58% wt/wt, an ionoflux of about2.9 (×10⁻³ mm²/min), a modulus of about 0.7 MPa, an elongation of about300%, a tensile strength of about 1.5 MPa, a captive bubble dynamicadvancing contact angle of from about 44 to about 48 degrees, a wetextractable component of about 5.10% wt/wt, and an energy loss fromabout 32% to about 33% when tested at the start of the shelf life study,and had an average dimensional stability variance less than plus orminus 3.0% after storage for 4.4 weeks at 80 degrees C. When testedprior to extraction and hydration, the polymeric lens bodies had a dryextractable component of about 12.2% wt/wt.

Example 18

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 29 Si2 8 VMA 45 HOB 7 EGMA 10EGDMA 0.5 TEGDVE 0.1 V-64 0.5 UV2 1.7 RBT2 0.01 pTPP 0.5 AE 0.3

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC from about 55% wt/wt to about 56% wt/wt, anionoflux of about 4.1 (×10⁻³ mm²/min), a modulus of about 0.6 MPa, anelongation of about 275%, a tensile strength of about 1.2 MPa, a captivebubble dynamic advancing contact angle of from about 55 to about 58degrees, a wet extractable component of about 4.6% wt/wt, an energy lossfrom about 31% to about 32%, and a swell factor of about 27% when testedat the start of the shelf life study, and had an average dimensionalstability variance less than plus or minus 3.0% for after storage for4.4 weeks at 80 degrees C. When tested prior to extraction andhydration, the polymeric lens bodies had a dry extractable component ofabout 10.6% wt/wt.

Example 19

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 30 Si2 7 VMA 44 MMA 8 EGMA 6BVE 4 DEGVE 10 EGDMA 0.6 TEGDVE 0.1 V-64 0.5 UV2 1.8 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC of about 61% wt/wt, an ionoflux of about 3.8 (×10⁻³mm²/min), a modulus of about 0.5 MPa, an elongation of about 279%, atensile strength of about 1.2 MPa, a captive bubble dynamic advancingcontact angle of from about 45 to about 47 degrees, a wet extractablecomponent of about 4.55% wt/wt, and an energy loss from about 30% toabout 33% when tested at the start of the shelf life study, and had anaverage dimensional stability variance less than plus or minus 3.0%after storage for 14 days at 80 degrees C. When tested prior toextraction and hydration, the polymeric lens bodies had a dryextractable component of about 13.65% wt/wt.

Example 20

A polymerizable composition was obtained by mixing and filtering thefollowing chemical compounds in the specified amounts, using theprocedure described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure given above.

Chemical Compound (Abbrev.) Unit parts Si1 30 Si2 7 VMA 45 MMA 12 EGMA 5BVE 5 TEGDMA 1.4 TEGDVE 0.2 V-64 0.5 UV2 1.8 RBT2 0.01 pTPP 0.5

A batch of silicone hydrogel contact lenses was prepared using thisformulation and tested in accordance with the fabrication procedure andtest methods described in the Silicone Hydrogel Contact Lens Fabricationand Testing Procedure, using a dry demolding process, a dry delensingprocess, and a washing process which used extraction and hydrationliquids consisting of volatile organic solvent-free extraction liquids.The lenses of this batch were not exposed to a volatile organic solventduring their manufacture. These contact lenses contained units derivedfrom two siloxane monomers, Si1 and Si2. This batch of contact lenseshad acceptable average dimensional stability variance.

In addition, these silicone hydrogel contact lenses, when fullyhydrated, had an EWC from about 55% wt/wt to about 57% wt/wt, anionoflux of about 3.6 (×10⁻³ mm²/min), a modulus of about 0.7 MPa, anelongation of about 285%, a tensile strength of about 1.3 MPa, a captivebubble dynamic advancing contact angle of from about 47 to about 53degrees, a wet extractable component of about 4.10% wt/wt, and an energyloss from about 34% to about 35% when tested at the start of the shelflife study, and had an average dimensional stability variance less thanplus or minus 3.0% after storage for 14 days at 80 degrees C. Whentested prior to extraction and hydration, the polymeric lens bodies werefound to have a dry extractable component of about 9.80% wt/wt.

Although the disclosure herein refers to certain illustratedembodiments, it is to be understood that these embodiments are presentedby way of example and not by way of limitation. The intent of theforegoing detailed description, although discussing exemplaryembodiments, is to be construed to cover all modifications,alternatives, and equivalents of the embodiments as may fall within thespirit and scope of the invention as defined by the additionaldisclosure.

A number of publications and patents have been cited hereinabove. Eachof the cited publications and patents are hereby incorporated byreference in their entireties.

What is claimed is:
 1. A method of manufacturing a batch of siliconehydrogel contact lenses, comprising: providing polymerized siliconehydrogel contact lens bodies in contact lens mold assemblies, wherein asingle polymerized silicone hydrogel contact lens body is provided in asingle contact lens mold assembly, and each contact lens mold assemblycomprises a first mold section having a concave optical surface forforming an anterior surface of the silicone hydrogel contact lens bodyand a second mold section having a convex optical surface for forming aposterior surface of the silicone hydrogel contact lens body, and thefirst mold section and second mold section are coupled together;separating the polymerized silicone hydrogel contact lens bodies fromthe contact lens mold assemblies to produce delensed contact lensbodies; washing the delensed contact lens bodies with an aqueous liquidfree of volatile organic solvent to produce washed contact lenses; andsterilizing the washed contact lenses in sealed contact lens packages;wherein the batch so manufactured comprises at least twenty siliconehydrogel contact lenses, and the anterior surfaces of the sterilizedcontact lenses have clinically acceptable surface wettabilities suchthat less than five percent of the silicone hydrogel contact lenses havevisually identifiable non-wetting spots when located on eyes ofsubjects, and wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the contact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×; whereina polymerizable composition used to form the polymerized siliconehydrogel contact lens bodies comprises a siloxane monomer represented byformula (1):

wherein m of formula (1) represents one integer from 3 to 10, n offormula (1) represents one integer from 1 to 10, R¹ of formula (1) is analkyl group having from 1 to 4 carbon atoms, and each R² of formula (1)is independently either a hydrogen atom or a methyl group; and whereinthe polymerized silicone hydrogel contact lens bodies comprise acopolymer including polymerized units of the siloxane monomerrepresented by formula (1).
 2. The method of claim 1, wherein at leastone of the first mold section or the second mold section comprises apolar resin having a polarity from 1% to 7%.
 3. The method of claim 1,wherein at least one of the first mold section or the second moldsection comprises a polybutylene terephthalate (PBT) resin.
 4. Themethod of claim 1, wherein each polymerized contact lens body isobtained by polymerizing a polymerizable composition in a contact lensmold assembly using thermal radiation, or ultraviolet radiation, orboth.
 5. The method of claim 1, wherein each polymerized siliconehydrogel contact lens body is obtained by polymerizing a polymerizablecomposition comprising a first siloxane monomer, a second siloxanemonomer, at least one hydrophilic monomer, at least one hydrophobicmonomer, and at least one cross-linking agent, and said polymerizablecomposition is free of a diluent, or free of a hydrophilic polymer, orboth.
 6. The method of claim 5, wherein the polymerizable compositioncomprises at least one hydrophilic vinyl monomer and at least one vinylcross-linking agent.
 7. The method of claim 1, wherein the batch ofsterilized silicone hydrogel contact lenses has an average diameter thatis at least 20% greater than the average diameter of the same batch ofsilicone hydrogel contact lens bodies prior to the washing step.
 8. Themethod of claim 1, wherein each of the sterilized silicone hydrogelcontact lenses has an oxygen permeability of at least 55 barrers, or anequilibrium water content from about 30% wt/wt to about 70% wt/wt, or atensile modulus from about 0.2 MPa to about 0.9 MPa, or any combinationthereof.
 9. A method of manufacturing a batch of silicone hydrogelcontact lenses, comprising: providing polymerized silicone hydrogelcontact lens bodies in contact lens mold assemblies, wherein a singlepolymerized silicone hydrogel contact lens body is provided in a singlecontact lens mold assembly, and each contact lens mold assemblycomprises a first mold section having a concave optical surface forforming an anterior surface of the silicone hydrogel contact lens bodyand a second mold section having a convex optical surface for forming aposterior surface of the silicone hydrogel contact lens body, and thefirst mold section and second mold section are coupled together;separating the polymerized silicone hydrogel contact lens bodies fromthe contact lens mold assemblies to produce delensed contact lensbodies; washing the delensed contact lens bodies with an aqueous liquidfree of volatile organic solvent to produce washed contact lenses; andsterilizing the washed contact lenses in sealed contact lens packages;wherein the batch so manufactured comprises at least twenty siliconehydrogel contact lenses, and the anterior surfaces of the sterilizedcontact lenses have clinically acceptable surface wettabilities suchthat less than five percent of the silicone hydrogel contact lenses havevisually identifiable non-wetting spots when located on eyes ofsubjects, and wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the contact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×, whereina polymerizable composition used to form the polymerized siliconehydrogel contact lens bodies comprises a siloxane monomer represented byformula (2):

wherein R₁ of formula (2) is selected from either hydrogen atom or amethyl group; R₂ of formula (2) is selected from either of hydrogen atomor a hydrocarbon group having 1 to 4 carbon atoms; m of formula (2)represents an integer of from 0 to 10; n of formula (2) represents aninteger of from 4 to 100; a and b represent integers of 1 or more; a+bis equal to 20-500; b/(a+b) is equal to 0.01-0.22; and the configurationof siloxane units includes a random configuration; and wherein thepolymerized silicone hydrogel contact lens bodies comprise a copolymerincluding polymerized units of the siloxane monomer represented byformula (2).
 10. A method of manufacturing a batch of silicone hydrogelcontact lenses, comprising: providing polymerized silicone hydrogelcontact lens bodies in contact lens mold assemblies, wherein a singlepolymerized silicone hydrogel contact lens body is provided in a singlecontact lens mold assembly, and each contact lens mold assemblycomprises a first mold section having a concave optical surface forforming an anterior surface of the silicone hydrogel contact lens bodyand a second mold section having a convex optical surface for forming aposterior surface of the silicone hydrogel contact lens body, and thefirst mold section and second mold section are coupled together;separating the polymerized silicone hydrogel contact lens bodies fromthe contact lens mold assemblies to produce delensed contact lensbodies; washing the delensed contact lens bodies with an aqueous liquidfree of volatile organic solvent to produce washed contact lenses; andsterilizing the washed contact lenses in sealed contact lens packages;wherein the batch so manufactured comprises at least twenty siliconehydrogel contact lenses, and the anterior surfaces of the sterilizedcontact lenses have clinically acceptable surface wettabilities suchthat less than five percent of the silicone hydrogel contact lenses havevisually identifiable non-wetting spots when located on eyes ofsubjects, and wherein the non-wetting spots are discontinuities of thecontact lens wearer's pre-lens tear film present on the anterior surfaceof the contact lens, and are visually identifiable during a slit lampexamination at a total magnification from about 6× to about 70×, whereina polymerizable composition used to form the polymerized siliconehydrogel contact lens bodies comprises a siloxane monomer represented byformula (6):

wherein n is an integer from 13-16, and the molecular weight is about1500 daltons; and wherein the polymerized silicone hydrogel contact lensbodies comprise a copolymer including polymerized units of the siloxanemonomer represented by formula (6).
 11. The method of claim 1, wherein apolymerizable composition used to form the polymerized silicone hydrogelcontact lens bodies comprises a hydrophilic amide monomer having oneN-vinyl group, and the polymerized silicone hydrogel contact lens bodiescomprise a copolymer including polymerized units of the hydrophilicamide monomer having one N-vinyl group.
 12. The method of claim 1,wherein a polymerizable composition used to form the polymerizedsilicone hydrogel contact lens bodies comprises a vinyl-containingcross-linking agent, and the polymerized silicone hydrogel contact lensbodies comprise a copolymer including polymerized units of thevinyl-containing cross-linking agent.
 13. A batch of silicone hydrogelcontact lenses, the batch comprising: at least twenty silicone hydrogelcontact lenses, each silicone hydrogel contact lens of the batch is anaqueous extracted silicone hydrogel contact lens comprising an anteriorsurface and an opposing posterior surface, the posterior surfacedimensioned by size and shape for placement against a subject's eye; theanterior surface of each of the aqueous extracted contact lenses havinga clinically acceptable surface wettability, such that less than fivepercent of the batch of silicone hydrogel contact lenses has visuallyidentifiable non-wetting spots when located on eyes of subject; whereinthe non-wetting spots are discontinuities of the contact lens wearer'spre-lens tear film present on the anterior surface of the contactlenses, and are visually identifiable during a slit lamp examination ata total magnification from about 6× to about 70×, and wherein a) apolymerizable composition used to form the silicone hydrogel contactlenses comprises a siloxane monomer represented by formula (1):

wherein m of formula (1) represents one integer from 3 to 10, n offormula (1) represents one integer from 1 to 10, R¹ of formula (1) is analkyl group having from 1 to 4 carbon atoms, and each R² of formula (1)is independently either a hydrogen atom or a methyl group; and whereinthe silicone hydrogel contact lenses comprise a copolymer includingpolymerized units of the siloxane monomer represented by formula (1), orb) the polymerizable composition used to form the silicone hydrogelcontact lenses comprises a siloxane monomer represented by formula (2):

wherein R₁ of formula (2) is selected from either hydrogen atom or amethyl group; R₂ of formula (2) is selected from either of hydrogen atomor a hydrocarbon group having 1 to 4 carbon atoms; m of formula (2)represents an integer of from 0 to 10; n of formula (2) represents aninteger of from 4 to 100; a and b represent integers of 1 or more; a+bis equal to 20-500; b/(a+b) is equal to 0.01-0.22; and the configurationof siloxane units includes a random configuration; and wherein thesilicone hydrogel contact lenses comprise a copolymer includingpolymerized units of the siloxane monomer represented by formula (2), orc) the polymerizable composition used to form the silicone hydrogelcontact lenses comprises a siloxane monomer represented by formula (6):

wherein n is an integer from 13-16, and the molecular weight is about1500 daltons; and wherein the silicone hydrogel contact lenses comprisea copolymer including polymerized units of the siloxane monomerrepresented by formula (6).
 14. The batch of silicone hydrogel contactlenses of claim 13, wherein each silicone hydrogel contact lens is acast molded silicone hydrogel contact lens without a plasma surfacetreatment or a polymeric internal wetting agent provided by including ahydrophilic polymer in the polymerizable composition used to form thesilicone hydrogel contact lens.
 15. The batch of silicone hydrogelcontact lenses of claim 13, wherein each silicone hydrogel contact lensis a cast molded silicone hydrogel contact lens obtained from a contactlens mold assembly, the contact lens mold assembly comprising ananterior mold member and a posterior mold member, each mold member beingformed from a polar resin having a polarity from about 1% to about 7%.16. The batch of silicone hydrogel contact lenses of claim 15, whereinthe polar resin is polybutylene terephthalate (PBT).
 17. The batch ofsilicone hydrogel contact lenses of claim 13, wherein each contact lenscomprises a polymeric component and a liquid component, the polymericcomponent comprising units of at least one siloxane having one or morefunctional acrylic groups, and units of one or more hydrophilic monomershaving one or more functional non-acrylic vinyl groups.
 18. The batch ofsilicone hydrogel contact lenses of claim 13, wherein each contact lenshas an oxygen permeability of at least 55 barrers, or an equilibriumwater content from about 30% wt/wt to about 70% wt/wt, or a tensilemodulus from about 0.2 MPa to about 0.9 MPa, or any combination thereof.19. The batch of silicone hydrogel contact lenses of claim 13, whereineach silicone hydrogel is provided in a sterilized contact lenspackaging solution, and each lens body has a wet extractable contentless than 10% (wt/wt).
 20. The method of claim 9, wherein at least oneof the first mold section or the second mold section comprises a polarresin having a polarity from 1% to 7%.
 21. The method of claim 9,wherein at least one of the first mold section or the second moldsection comprises a polybutylene terephthalate (PBT) resin.
 22. Themethod of claim 9, wherein each polymerized contact lens body isobtained by polymerizing a polymerizable composition in a contact lensmold assembly using thermal radiation, or ultraviolet radiation, orboth.
 23. The method of claim 9, wherein each polymerized siliconehydrogel contact lens body is obtained by polymerizing a polymerizablecomposition comprising a first siloxane monomer, a second siloxanemonomer, at least one hydrophilic monomer, at least one hydrophobicmonomer, and at least one cross-linking agent, and said polymerizablecomposition is free of a diluent, or free of a hydrophilic polymer, orboth.
 24. The method of claim 23, wherein the polymerizable compositioncomprises at least one hydrophilic vinyl monomer and at least one vinylcross-linking agent.
 25. The method of claim 9, wherein the batch ofsterilized silicone hydrogel contact lenses has an average diameter thatis at least 20% greater than the average diameter of the same batch ofsilicone hydrogel contact lens bodies prior to the washing step.
 26. Themethod of claim 9, wherein each of the sterilized silicone hydrogelcontact lenses has an oxygen permeability of at least 55 barrers, or anequilibrium water content from about 30% wt/wt to about 70% wt/wt, or atensile modulus from about 0.2 MPa to about 0.9 MPa, or any combinationthereof.
 27. The method of claim 9, wherein a polymerizable compositionused to form the polymerized silicone hydrogel contact lens bodiescomprises a hydrophilic amide monomer having one N-vinyl group, and thepolymerized silicone hydrogel contact lens bodies comprise a copolymerincluding polymerized units of the hydrophilic amide monomer having oneN-vinyl group.
 28. The method of claim 9, wherein a polymerizablecomposition used to form the polymerized silicone hydrogel contact lensbodies comprises a vinyl-containing cross-linking agent, and thepolymerized silicone hydrogel contact lens bodies comprise a copolymerincluding polymerized units of the vinyl-containing cross-linking agent.29. The method of claim 10, wherein at least one of the first moldsection or the second mold section comprises a polar resin having apolarity from 1% to 7%.
 30. The method of claim 10, wherein at least oneof the first mold section or the second mold section comprises apolybutylene terephthalate (PBT) resin.
 31. The method of claim 10,wherein each polymerized contact lens body is obtained by polymerizing apolymerizable composition in a contact lens mold assembly using thermalradiation, or ultraviolet radiation, or both.
 32. The method of claim10, wherein each polymerized silicone hydrogel contact lens body isobtained by polymerizing a polymerizable composition comprising a firstsiloxane monomer, a second siloxane monomer, at least one hydrophilicmonomer, at least one hydrophobic monomer, and at least onecross-linking agent, and said polymerizable composition is free of adiluent, or free of a hydrophilic polymer, or both.
 33. The method ofclaim 32, wherein the polymerizable composition comprises at least onehydrophilic vinyl monomer and at least one vinyl cross-linking agent.34. The method of claim 10, wherein the batch of sterilized siliconehydrogel contact lenses has an average diameter that is at least 20%greater than the average diameter of the same batch of silicone hydrogelcontact lens bodies prior to the washing step.
 35. The method of claim10, wherein each of the sterilized silicone hydrogel contact lenses hasan oxygen permeability of at least 55 barrers, or an equilibrium watercontent from about 30% wt/wt to about 70% wt/wt, or a tensile modulusfrom about 0.2 MPa to about 0.9 MPa, or any combination thereof.
 36. Themethod of claim 10, wherein a polymerizable composition used to form thepolymerized silicone hydrogel contact lens bodies comprises ahydrophilic amide monomer having one N-vinyl group, and the polymerizedsilicone hydrogel contact lens bodies comprise a copolymer includingpolymerized units of the hydrophilic amide monomer having one N-vinylgroup.
 37. The method of claim 10, wherein a polymerizable compositionused to form the polymerized silicone hydrogel contact lens bodiescomprises a vinyl-containing cross-linking agent, and the polymerizedsilicone hydrogel contact lens bodies comprise a copolymer includingpolymerized units of the vinyl-containing cross-linking agent.
 38. Thebatch of claim 13, wherein the polymerizable composition used to formthe silicone hydrogel contact lenses comprises a siloxane monomerrepresented by formula (1):

wherein m of formula (1) represents one integer from 3 to 10, n offormula (1) represents one integer from 1 to 10, R¹ of formula (1) is analkyl group having from 1 to 4 carbon atoms, and each R² of formula (1)is independently either a hydrogen atom or a methyl group; and whereinthe silicone hydrogel contact lenses comprise a copolymer includingpolymerized units of the siloxane monomer represented by formula (1).39. The batch of claim 13, wherein the polymerizable composition used toform the silicone hydrogel contact lenses comprises a siloxane monomerrepresented by formula (2):

wherein R₁ of formula (2) is selected from either hydrogen atom or amethyl group; R₂ of formula (2) is selected from either of hydrogen atomor a hydrocarbon group having 1 to 4 carbon atoms; m of formula (2)represents an integer of from 0 to 10; n of formula (2) represents aninteger of from 4 to 100; a and b represent integers of 1 or more; a+bis equal to 20-500; b/(a+b) is equal to 0.01-0.22; and the configurationof siloxane units includes a random configuration; and wherein thepolymerized silicone hydrogel contact lenses comprise a copolymerincluding units of the siloxane monomer represented by formula (2). 40.The batch of claim 13, wherein the polymerizable composition used toform the silicone hydrogel contact lenses comprises a siloxane monomerrepresented by formula (6):

wherein n is an integer from 13-16, and the molecular weight is about1500 daltons; and wherein the silicone hydrogel contact lenses comprisea copolymer including polymerized units of the siloxane monomerrepresented by formula (6).